Interest of Clomiphene Citrate (CC) Associated With a Second Testicular Sperm Extraction (TESE) in Patients With Non-obstructive Azoospermia (NOA) After Failure of a First TESE, on the Quantity of Sperm Cells Available for Intracytoplasmic Sperm Injection (ICSI). Randomized Double Blind Trial Versus Placebo.

In the absence of sperm in the semen (azoospermia), there is no chance of natural paternity. It is found in about 1% of men and is either due to an obstruction of the seminal tracks (obstructive azoospermia (OA)) in 1/3 of the cases, or a spermatogenic failure (non-obstructive azoospermia (NOA)) in 2/3 of the cases. To date, no medical treatment had proved its efficiency to induce spermatogenesis in case of NOA.
The development of Intracytoplasmic sperm injection (ICSI) in 1992 allowed to obtain pregnancies from a small number of spermatozoa. The next year, testicular sperms were extracted from testicular tissue obtained surgically in cases of OA , allowing paternity for azoospermic men. In case of NOA, TESE allowed to obtain few sperms in an unexpected number of cases. It was shown that spermatogenesis remains active in rare portions of seminiferous tubules, a phenomenon called focal spermatogenesis, which allows to extract testicular sperms with an average SRR of 50%, and to obtain pregnancy by ICSI. Thus, TESE-ICSI revolutionized the prognosis of NOA, however, half of the cases of NOA had no sperm extracted and remained sterile . Since sperm donation and adoption are unacceptable for several of these couples, there is a real demand for additional treatment.
Two ways to improve chances of paternity in case of NOA are currently discussed:
1. Proceed to a second attempt of TESE. Since the first attempt could have missed a focus of active spermatogenesis, the chance for a positive second TESE is not null even. Reviewing the few articles published on this issue , the SRR for the second attempt, after a first negative attempt averaged 25%.
2. Based upon the decrease of testosterone production within the testis in case of NOA and the potential increased of the focal spermatogenesis by gonadotropins, few reports of hormonal therapy in case of NOA have been published and suggested a positive effect of hormonal therapy.
This prompted us to develop this clinical trial to investigate the effect of Clomiphene Citrate versus placebo on the results of a second TESE in NOA.
Results of hormonal therapy in case of NOA were heterogeneous and of poor methodological quality, none was randomized versus placebo: Anti-aromatases or Gonadotropins administered before the first TESE or the second TESE gave positive results. Hussein at al in 2013, suggested a positive effect of Clomiphene citrate (CC), administrated before the first TESE (57% of the CC treated group versus 33.6% in not treated group) but with drop out of patient positive to sperm analysis. However, in these positive studies, sample sizes were small or selected patients on hormonal status or histology criteria suggesting subgroup of favourable NOA. Thus, there is no strong evaluation of the interest of hormonal treatment in NOA, after a negative first TESE.
The investigators decided to evaluate the effect of the CC, the most convincing and convenient hormonal treatment, in patients with negative first TESE for NOA. It is of main interest to known if CC could enhance the SRR of a second TESE, that is the ultimate possibility to have their own child for these patients.

开始日期2026-01-01

申办/合作机构

Hospices Civils de Lyon

NCT06701071

/ Recruiting临床4期IIT

Evaluation of a Long Versus Short Clomid Protocol for Controlled Ovarian Stimulation in Patients With Diminished Ovarian Reserve Undergoing In-vitro Fertilization: a Randomized Controlled Trial

The goal of this clinical trial is to evaluate a long Clomid protocol as compared to a 5-day Clomid protocol for ovarian stimulation in patients with diminished ovarian reserve undergoing ovarian stimulation for in-vitro fertilization. The aim of the long Clomid protocol is to intensify stimulation of the ovaries and reduce both cost and injection burden for patients. Participants will be randomized to receive the long Clomid protocol vs. the typical protocol involving Clomid only for 5 days followed by growth hormone-releasing hormone (GnRH) antagonist. The primary outcome the investigators will evaluate will be the number of mature eggs retrieved.

开始日期2025-06-01

申办/合作机构

University of Southern California

CTRI/2025/04/084166

/ Not yet recruitingN/A

To assess the efficacy of clomiphene citrate flare effect in the flexible antagonist protocol versus ultra short flare agonist protocol in diminished ovarian reserve. - NIL

开始日期2025-04-10

申办/合作机构-

100 项与枸橼酸氯米芬相关的临床结果

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100 项与枸橼酸氯米芬相关的转化医学

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100 项与枸橼酸氯米芬相关的专利（医药）

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项与枸橼酸氯米芬相关的文献（医药）

2025-11-01·European Journal of Obstetrics & Gynecology and Reproductive Biology

Ovarian response in natural cycle, minimal stimulation and conventional IVF protocols in relation to anti-mullerian hormone level – A multi-center study

Article

作者: von Arnim, L ; Nordin, M ; Bohlen, U ; von Wolff, M ; Popovici, R M ; Lühr, B ; Lanowski, J-S ; Arni, A ; Roumet, M ; Eisenhardt, S ; Magaton, I ; Siercks, I ; Reeka, N

BACKGROUND:

In addition to conventional in-vitro-fertilization IVF (cIVF) alternative protocols such as natural cycle (NC-) and minimal stimulation (Min stim-) protocols allow individualized IVF and oocyte freezing treatments. The objective was to develop a model to predict ovarian response in relation to different stimulation protocols and anti-mullerian hormone (AMH) levels.

METHODS:

International multi-centre retrospective cohort study including 1504 NC-IVF, 1287 Min stim IVF and 2048 cIVF cycles performed 01.2022-03.2023. Min stim protocols consisted of oral compounds such as low dose clomiphene citrate or aromatase inhibitors alone or in combination with low dose gonadotropins. Negative binomial regression models were used to assess the effect of protocol and AMH level on the number of oocytes and secondarily on zygotes. Predictions of outcomes were derived across protocols and different AMH categories (<1, ≥1-<2, ≥2 ng/ml).

RESULTS:

AMH is an effective predictor of the number of oocytes in relation to IVF protocol. Number of oocytes increase in protocols including gonadotropins, but not in protocols with only oral compounds. Effect of stimulation increased with increasing AMH level but was less pronounced with low AMH level. For example, if AMH is < 1 ng/ml, the predicted number of oocytes is 0.85 and 4.04 in the NC- and cIVF protocols, whereas the difference is twice as large with AMH ≥ 2 ng/ml with predicted values of 0.83 and 10.54, respectively.

CONCLUSION:

Based on AMH level, Min stim-protocols can be individualized by selecting specific stimulation protocols according to the predicted ovarian response, especially in cases with low ovarian reserve.

2025-10-03·AMERICAN JOURNAL OF VETERINARY RESEARCH

Intravenous clomiphene citrate pharmacokinetics in healthy mares as a first step toward use in reproduction

Article

作者: Thungrat, Kamoltip ; Cruz-Espindola, Crisanta ; Moore, Hayley L. ; Klabnik, Jessica L. ; Boothe, Dawn M. ; Mita, Nur ; Babu, R. Jayachandra ; Lyman, Candace C.

Abstract:

Objective:

To investigate the IV pharmacokinetic parameters of clomiphene citrate (CC), a selective estrogen receptor modulator, in mares.

Methods:

This was an experimental study to assess the pharmacokinetic parameters of CC in the mare. Eight mares received a single 2,000-mg dose of IV CC to identify plasma concentrations over 336 hours. Following this, 6 mares received a multidose regimen of IV CC (2,000 mg, q 24 h) for 5 days to identify trough plasma concentration each day.

Results:

CC was well tolerated, demonstrated a short elimination half-life of 4.95 ± 1.10 hours and a mean residence time of 7.14 ± 1.59 hours, and reached plasma drug concentrations considered to be therapeutic in women. Peak and trough plasma concentrations were determined.

Conclusions:

IV CC at 2,000 mg reaches presumed therapeutic concentrations in the mare. Based on the multidose trial, 2,000 mg of IV CC may require administration every 12 to 24 hours.

Clinical Relevance:

IV CC appears to be well tolerated in the mare. Future fertility trials are warranted to assess the potential that CC may have in increasing the efficiency of equine in vitro embryo production.

2025-10-01·JOURNAL OF MOLECULAR HISTOLOGY

Kaempferol alleviates cypermethrin induced reproductive toxicity in rats via Nrf2-mediated antioxidant and apoptotic regulation with histopathological evidence: in vivo and in silico study

Article

作者: Din, Hafiz Misbah Ud ; Usman, Muhammad ; Azeem, Muhammad ; Nazir, Sadaf ; Anjum, Shaista ; Khan, Nazima Yousaf ; Buzdar, Jameel Ahmed ; Behan, Atique Ahmed ; Arshad, Muhammad Adeel ; Cheng, Shiping ; Kabeer, Fahad

Cypermethrin (CYP), a common synthetic pyrethroid pesticide, is associated with oxidative stress-mediated female reproductive toxicity. With increasing concern over reproductive failures, exploring natural alternatives to mitigate this problem is crucial. For this purpose, thirty-six female SD rats were divided into six different (n = 6) groups such as negative control (group I), while disease control (group II) was treated to CYP-induced toxicity. Group III received 5 mg/kg Clomiphene Citrate, a standard drug, and groups IV, V, and VI were subjected with Kaempferol (KAE) dosage of 25, 50 and 100 mg/kg, respectively, for 14 days after induction of toxicity. CYP exposure significantly impaired the fertility status of female rats, disrupted the estrous cycle, altered ovarian and uterine coefficients. It also reduced antioxidant enzyme activity while elevating malondialdehyde levels. KAE supplementation effectively reversed these changes by restoring fertility status, normalizing antioxidant enzyme activity and reducing MDA levels, and improving ovarian and uterine coefficients. Histopathological analysis revealed preserved uterine and ovarian integrity in KAE-treated groups. Furthermore, KAE regulated the mRNA expression of key apoptotic and oxidative stress markers including Bcl2, Bax, caspase-3, caspase-9, and Nrf2. Further, gene ontological study revealed that these genes are involved in apoptotic signaling, immune homeostasis and neuronal regulation due to strong enrichment in mitochondrial and protease related function. Molecular docking analysis demonstrated that KAE exhibited significantly, inhibit Nrf2-KEAP1 bonding compared to Clomiphene citrate, indicated by well docking score. It is concluded that KAE holds therapeutic potential as a safe, natural alternative to combat CYP induced oxidative stress, apoptosis, and reproductive toxicity.

项与枸橼酸氯米芬相关的新闻（医药）

2025-07-30

·EINPresswire

MOPE Clinic Highlights Clomiphene/Enclomiphene as Innovative Alternatives to Testosterone Replacement Therapy for Men

The Pros and Cons of Boosting Natural Testosterone Production with Selective Estrogen Receptor Modulators (SERMs) Clomiphene and Enclomiphene represent a revolutionary shift in how we manage low testosterone in men through enhancing the body’s natural hormone production as an alternative to traditional TRT.” — Chris Rue, FNP-C METAIRIE, LA, UNITED STATES, July 30, 2025 / EINPresswire.com / -- Metairie, LA– As the conversation around men’s hormonal health continues to grow, MOPE Clinic and Chris Rue, FNP-C are helping to lead the way in providing evidence-based options for testosterone optimization. One of the most compelling developments in this area is the use of medications like Clomiphene citrate and Enclomiphene citrate to stimulate the body’s own production of testosterone. These compounds, known as Selective Estrogen Receptor Modulators (SERMs), have gained popularity among men looking for an alternative to traditional testosterone replacement therapy (TRT). At MOPE Clinic, patients receive personalized, safe, and medically supervised hormone care tailored to their unique needs. What Are Clomiphene and Enclomiphene? Clomiphene citrate is a well-known fertility medication that has long been used in women. However, in recent years, it has found an important place in men’s health care. Enclomiphene, its purified isomer, has emerged as a more targeted treatment option with fewer estrogenic side effects. Both medications work by blocking estrogen receptors in the hypothalamus. This action tricks the brain into thinking estrogen levels are low, which leads to an increase in gonadotropin-releasing hormone (GnRH). In turn, GnRH stimulates the pituitary gland to produce luteinizing hormone (LH) and follicle-stimulating hormone (FSH). These hormones tell the testes to produce more testosterone and sperm. In other words, Clomiphene and Enclomiphene help reactivate the body’s natural testosterone production—a critical distinction from TRT, which replaces testosterone from external sources and often shuts down the body’s own production. The Benefits of Clomiphene and Enclomiphene At MOPE Clinic, Chris Rue, FNP-C emphasizes a holistic, functional approach to hormone optimization. In that light, Clomiphene and Enclomiphene offer several unique advantages: 1. Preservation of Fertility Unlike TRT, which can suppress sperm production, Clomiphene and Enclomiphene support spermatogenesis. This makes them ideal for younger men or those planning to maintain fertility while improving their testosterone levels. 2. Endogenous Testosterone Production These SERMs stimulate the body’s own production of testosterone. This avoids the testicular shrinkage and hypothalamic-pituitary-testicular axis (HPTA) suppression commonly seen with TRT. 3. Oral Administration Clomiphene and Enclomiphene are taken orally, typically as a pill taken daily or several times per week. This is more convenient than injections, gels, or pellets required in most TRT protocols. 4. Lower Risk of Erythrocytosis TRT can increase red blood cell count, raising the risk of blood clots. Clomiphene and Enclomiphene pose a lower risk for this complication. 5. Fewer Legal and Regulatory Concerns Clomiphene and Enclomiphene are not classified as controlled substances in the United States. This makes prescribing and accessing them more straightforward for both providers and patients. Who Is a Good Candidate? According to Chris Rue, FNP-C, ideal candidates for Clomiphene or Enclomiphene therapy include: Men under age 50 experiencing symptoms of low testosterone (fatigue, low libido, mood changes, etc.) Patients who still want to preserve fertility Individuals hesitant to start long-term TRT Men with secondary hypogonadism, where the problem lies in the brain or pituitary, not the testes At MOPE Clinic, patients undergo comprehensive lab testing, physical exams, and hormone assessments to determine whether Clomiphene or Enclomiphene is an appropriate treatment option. What Are the Limitations? Despite their many benefits, Clomiphene and Enclomiphene are not perfect solutions for every patient. At MOPE Clinic, education and transparency are key. Here are the primary limitations patients should consider: 1. Not Effective for Primary Hypogonadism If the testes are damaged or unresponsive (primary hypogonadism), Clomiphene and Enclomiphene won’t help. These medications require a functioning hypothalamic-pituitary-testicular axis. 2. Estrogenic Side Effects (Clomiphene) Some men experience visual disturbances, mood swings, or gynecomastia (breast tissue development) due to the mixed estrogenic effects of Clomiphene. Enclomiphene, being the purified isomer, generally causes fewer of these issues. 3. Variable Response Not all men respond the same. Some may see only modest increases in testosterone or symptom improvement. Ongoing monitoring is essential. 4. Off-Label Use Currently, neither Clomiphene nor Enclomiphene is FDA-approved specifically for male hypogonadism. However, off-label use is common and backed by numerous clinical studies. 5. Requires Patience and Follow-Up Clomiphene and Enclomiphene require several weeks to months to fully evaluate effectiveness. Frequent follow-up lab testing is necessary to track LH, FSH, estradiol, and testosterone levels. Research and Clinical Evidence Clinical studies have demonstrated the efficacy of Clomiphene citrate in raising testosterone levels in men with secondary hypogonadism. One study published in Fertility and Sterility showed that Clomiphene increased serum testosterone from an average of 247 ng/dL to 610 ng/dL after 3 months of therapy ( https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/16422830/ } Another study in The Journal of Urology found that Enclomiphene significantly increased testosterone levels while maintaining sperm production—something not typically seen with TRT ( https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/26496621/ ) MOPE Clinic’s Personalized Approach At MOPE Clinic, Chris Rue, FNP-C ensures that every patient receives a tailored treatment plan that considers hormonal balance, lifestyle, nutrition, and long-term health. Rather than treating labs alone, the clinic focuses on relieving symptoms, restoring well-being, and preserving function. Patients receive ongoing support, education, and adjustments to therapy as needed. Whether you’re struggling with fatigue, weight gain, low libido, or brain fog, MOPE Clinic offers a comprehensive, patient-first approach to hormonal health. Conclusion: A Modern Option for a Modern Man Clomiphene and Enclomiphene represent a revolutionary shift in how we manage low testosterone in men. By enhancing the body’s natural hormone production, these medications provide a compelling alternative to conventional testosterone replacement therapy. Still, they are not without limitations. At MOPE Clinic, men can expect evidence-based guidance, thorough evaluations, and compassionate care that respects their goals—whether that’s reclaiming energy, improving libido, or preserving fertility. Schedule a Consultation Today Men interested in learning whether Clomiphene or Enclomiphene is right for them can schedule a consultation at MOPE Clinic with Chris Rue, FNP-C. About MOPE Clinic MOPE Clinic is a leading hormone optimization and wellness center dedicated to improving men’s and women’s health through personalized, research-backed care. Led by Chris Rue, FNP-C, the clinic specializes in testosterone optimization, peptide therapy, weight loss solutions, and integrative functional medicine. Chris Rue Metairie Optimal Performance Enhancement +1 504-265-5491 email us here Visit us on social media: LinkedIn Instagram Facebook Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

临床结果

2025-06-17

·EINPresswire

Perform Medical Launches Comprehensive Hormone Balancing Program for Men and Women in the Greater Charleston Area

SUMMERVILLE, SC, UNITED STATES, June 17, 2025 / EINPresswire.com / -- Perform Medical , a premier wellness clinic serving the Lowcountry, proudly announces the launch of its advanced, personalized hormone balancing programs for both men and women. Under the clinical leadership of Taylor Vaughan, Medical Director, MBA, and Kaley Morris, Physician Assistant, the initiative offers an integrative, results-driven approach to correcting hormonal imbalances that impact health, vitality, and quality of life. At Perform Medical, the mission is clear: Reclaim Your Health, Hormone by Hormone. With the understanding that hormone shifts are a natural part of aging, the clinic empowers patients to stop merely enduring the symptoms and instead regain their energy, clarity, and confidence through customized hormone therapy. Why Hormone Balance Matters Hormones govern nearly every system in the human body—from metabolism and mood to sexual health and mental clarity. When these powerful messengers fall out of sync, patients may experience symptoms such as: - Chronic fatigue and poor sleep - Weight gain and muscle loss - Mood swings, anxiety, and depression - Low libido and sexual dysfunction - Brain fog and poor concentration - Hot flashes and night sweats Whether the imbalance stems from aging, menopause, andropause, or chronic stress, Perform Medical’s team addresses the root causes with medical precision and compassionate care. Tailored Care for Men Men facing symptoms of low testosterone—such as reduced motivation, decreased muscle mass, erectile dysfunction, and mental fog—can benefit from Perform Medical’s Testosterone Replacement Therapy (TRT). The clinic offers multiple delivery options, including bio-identical hormone pellets, injections, and fertility-preserving alternatives like Clomiphene or Enclomiphene. Each program begins with advanced hormone panel testing and includes ongoing lab monitoring to ensure optimal, long-lasting results. Estrogen blockers are also available to help manage potential side effects, ensuring that each plan is customized to the individual’s goals and lifestyle. Empowering Women Through Every Life Stage For women navigating perimenopause, menopause, or postmenopause, Perform Medical delivers cutting-edge bio-identical hormone replacement therapy (BHRT) to alleviate hot flashes, mood instability, low libido, and more. Led by Kaley Morris, PA-C, the women’s program includes pellet therapy, topical hormone creams, and integrated wellness support to restore balance naturally and effectively. The clinic’s BHRT pellets—plant-based and structurally identical to human hormones—offer long-term, steady-release dosing without the daily hassle of pills or creams. They are a preferred option for women seeking consistent relief and convenience. The Perform Medical Difference Perform Medical stands out for its deep specialization in hormonal health, evidenced by: - Expert Clinicians: Board-certified providers with advanced training in hormone therapy - Individualized Care Plans: No cookie-cutter protocols—just precision medicine based on lab data and symptoms - Local Support: A patient-first approach rooted in the Charleston community - Whole-Body Wellness: Hormone therapy integrated with sexual wellness, medical weight loss, and functional health programs Now Serving the Greater Charleston Area Perform Medical is currently welcoming patients from Summerville, Charleston, Mount Pleasant, Daniel Island, Isle of Palms, Sullivans Island, Kiawah Island, Moncks Corner, Goose Creek, and North Charleston. Is Hormone Therapy Right for You? If you’ve asked yourself questions like: - “Why am I tired all the time?” - “Is there a better way to handle menopause?” - “What can I do about brain fog and low libido?” - “Where can I get testosterone therapy in Charleston?” …it may be time to explore your hormonal health. To learn more or schedule their personalized hormone consultation, individuals can contact Perform Medical today at (843) 278-8474. About Perform Medical Perform Medical is a functional wellness clinic based in Charleston, SC, specializing in hormone health, sexual wellness, regenerative medicine, and medical weight loss. Led by Dr. Taylor Vaughan and Kaley Morris, PA-C, the clinic is dedicated to restoring health through advanced diagnostics, evidence-based therapies, and compassionate care. Taylor Vaughan, MD, MBA Perform Medical +1 843-278-8474 email us here Visit us on social media: Instagram Facebook Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

高管变更

2025-05-23

·舒泰神

一文读懂少弱精子症药物治疗现状及研发进展

据1995年世界卫生组织人类生殖特别规划署(WHO/HRP)统计显示，全球不孕夫妇已达6000~8000万对"。而后根据弗若斯特沙利文的研究称，全球不孕症患病率从1997年的11.0%上升到了2017年的15.0%，其中中国2017年也达到了15.5%。而男性不育患者中，少弱精子症者占了相当大比例，研究表明男性精液参数异常是导致男性不育的重要原因之一，主要表现为无精、严重少精、少精、畸精或弱精子症，其中少、弱精子症占了 3/4，是引起男性不育的最常见的原因。较精液参数正常者，弱精子症患者的不育风险增加 2~3倍，而少弱精子症患者不育风险增加 5~7 倍。在男性不育症中少精子症和弱精子症是其中两种最常见的病症，这两种病症都可能导致男性不育，它们有其共同之处，但在诊断、病因与治疗中也存在一些不同之处：少精子症定义及流行病学特征少精子症是指射出体外的精液中虽然有精子，但精子总数（或精子浓度）低于正常生育力男性精液检查参考值下限。根据《世界卫生组织人类精液检查与处理实验室手册（第5版）》的参考值，禁欲2~7 d，至少2次精液常规分析提示精液中虽然有精子，但1次射精的精子总数<39×106（或精子浓度<15×106/mL），而精液体积、精子活力、精子正常形态率等正常即可诊断为少精子症。据世界卫生组织（World Health Organization, WHO）报告，约15%的育龄夫妇患有不育症，而发展中国家的某些地区甚至高达30%。过去20年里，欧美发达国家男性的精子浓度以平均每年2.6%的速度下降。一项印度的研究统计了17 979例人群的精液检查结果，显示少精子症的发生率为22%；另一项在瑞士进行的一项全国性横断面调查表明，17%的男性精子浓度低于15×106/mL。弱精子症定义及流行病学特征精液中精子的运动可以分为快速向前运动（a级精子）、缓慢前向运动（b级精子）和非前向运动（c级精子）。《世界卫生组织人类精液检查与处理实验室手册》（第5版）不再区分a级和b级精子，统称为前向运动精子，并将精液中精子前向运动（progressive motility, PR）的百分率低于参考值下限（32%）且其他精液参数参考值在正常范围的病症定义为弱精子症。第5版手册同时给出了精子总活力（即前向运动和非前向运动精子总和）的参考值为40%。一般男性人群中弱精子症的患病率尚不清楚。男性不育或不孕不育夫妇中男性弱精子症的流行病学研究结果报道存在差异，患病率从10%至50%不等。这种差异可能与种族、生活习惯和地理环境等差异有关，也可能与调查人群的选择、调查方法的差异以及不同的诊断标准有关。但总体可以看出，弱精子症是男性不育的重要原因，患病人群庞大，临床上需要积极应对。少、弱精子症病因根据少，弱精子两份诊疗专家共识，少精弱精症病因复杂，可由单个因素或同时多个因素引起，部分病因不明，常见病因包括生殖系统疾病、免疫因素、遗传因素、内分泌因素、环境因素等。弱精子症与少精子症主要不同之处在于：弱精症的常见病因是生殖道感染、精索静脉曲张、射精管不全梗阻等，而少精症的病因还包括环境因素、放化疗后及生殖毒性药物、生活习惯、营养因素等。少、弱精子症治疗少、弱精子症的一般治疗：由于精子活力受生活习惯、环境及精神压力等因素的影响，临床治疗时要指导患者保持良好的生活习惯，禁烟，不过量或过频饮酒，少吃高脂肪食物，控制体重，适度运动，防止睡眠不足、熬夜和过度疲劳，缓解精神压力，避免接触环境中生殖毒性物质等。减肥、戒烟、戒酒、体育锻炼能够改善异常的精子参数、激素水平以及肥胖相关的继发性性腺功能减退症（secondary hypogonadism，SH），有利于不育症和实施辅助生殖技术（assisted reproductive technology，ART）治疗的结局。避免长期环境暴露因素和停用影响生精功能的药物。少精子症的药物治疗：（1）激素治疗①继发性性腺功能减退症：首先单独使用人绒毛膜促性腺激素（human chorionic gonadotropin， hCG）250 IU、每周2次启动，为了达到正常血清睾酮水平，可以高达2000 IU、每周2次；如果刺激精子发生失败，可以联用FSH（75~150 IU，每周3次）。尿液提取FSH、高纯化FSH与基因重组FSH的治疗效果没有差异。SH患者较大的基线睾丸体积与睾丸体积增加值是评价促性腺激素（gonadotrophin， Gn）治疗反应、诱导精子发生的最好预后指标［26-27］（2B）。②同化类固醇激素滥用：首先停用该类药物，一般6~12个月可以改善精子数量和质量；如果没有改善，尝试使用hCG，或者联合FSH和氯米芬的其中一种药物刺激精子发生［28］（2B）。（2）其他药物治疗：药物治疗仍然是治疗不育症的常用手段，最好在启动治疗前找到准确病因并针对病因用药，适用于少精子症、弱精子症、畸形精子症或者同时并存前述几种异常类型的患者。如果准备进行经验性药物治疗，则药物使用时间不应少于3~6个月，覆盖1~2个精子发生周期［6，29］（2B）。①抗氧化剂治疗：能够改善精液参数、降低精子DNA碎片率，对于实施ART周期、生育力低下夫妇的活产率和妊娠率均具有正性影响。少精子症是抗氧化剂治疗的适应证之一，常用药物包括维生素E （100 mg bid/tid，口服）、维生素C （200~300 mg bid/tid，口服）、（乙酰）左旋肉碱（1 g bid/tid，口服）、辅酶Q10 （30~100 mg qd，口服）以及叶酸、锌、硒微量元素等［30-31］（2B）。②选择性雌二醇受体调节剂（selective estrogen receptor modulators，SERMs）：推荐SERMs作为少精子症的一种经验性治疗方式，部分患者可以增加精子总数和精子浓度。常用药物包括氯米芬（25~50 mg/d，口服）和他莫昔芬（10~30 mg/d，口服）［32］（2C）。③芳香化酶抑制剂（aromatase inhibitors，AIs）：甾体类（睾内酯）或非甾体类（阿那曲唑、来曲唑）AIs能够增加内源性睾酮的水平、改善精子发生，显著改善睾丸功能障碍以及血清睾酮水平或睾酮/雌二醇比值降低的不育症男性的激素和精液参数。常用药物为来曲唑2.5 mg/d，口服［33］（2C）。（3）高泌乳素血症：不受病因影响（包括垂体腺瘤）的治疗方法包括多巴胺激动剂治疗（溴隐亭、卡麦角林、喹高利特）或者停用致病药物。常用药物为溴隐亭，2.5~7.5 mg/次，2~4次/d［34］（2C）。弱精子症的药物治疗：病因明确的，针对病因进行治疗。对于特发性弱精子症，选择经验性药物治疗。治疗时间一般以３个月一个治疗周期，治疗过程中需进一步评价治疗的疗效和安全性。1.基础药物治疗：多原因造成的弱精子症中氧化应激反应及其造成的细胞损伤是共同的发病机制，基础治疗中通常包括抗氧化剂。硒元素、联合左卡尼汀和乙酰左卡尼汀、辅酶Q10可以明显改善精子活力等参数，合用锌和叶酸、合用多不饱和脂肪酸EPA（eicosapentaenoic acid，二十碳五烯酸）和DHA（docosahexaenoic acid，二十二碳六烯酸）有助于妊娠率的提高。2.针对病因的药物治疗：（1）抗菌消炎药：明确的男性生殖道或附属性腺感染，应根据其临床症状和细菌学检查确诊，使用敏感的抗生素治疗。（2）内分泌疗法：对于生殖激素异常引起的，可选用促性腺激素、雌激素受体拮抗剂或芳香化酶抑制剂等调节生殖激素的方法。治疗要同时考虑生育结局，鉴于雄激素的使用可能会影响男性患者生精能力，故不推荐使用外源性雄激素治疗弱精子症。（3）改善局部血循环：精索静脉曲张引起的存在局部血循环障碍。拒绝或不适合手术治疗的患者尤其是轻中度精索静脉曲张，可使用七叶皂苷类或黄酮类药物增加血管弹性和张力，改善血循环，改善精子活力。3.中医中药治疗：中医药治疗有效性缺少强有力的循证医学证据，临床上谨慎使用。少弱精子症的治疗一直是男科医生的一大难题，各种经验性、非特异性的治疗方法试图用来提高弱精子症患者的精子参数和生育能力，但是疗效依然差强人意。大多数患者最后都需要求助于体外受精(IVF)或卵细胞胞质内单精子注射(ICSI)技术，而后者昂贵的价格和不可预知的治疗风险仍未得到很好的解决。而单从费用上考虑很多患者不愿意进行辅助生殖，因此，弱精子症的药物治疗需进一步深入的药物研发，从而为广大患者提供更优的药物选择。近年来发现神经生长因子（NGF）不仅对神经系统有作用，而且对生殖系统也有十分重要的作用。基础研究表明，NGF在雄性生殖系统的发育、分化和生理功能方面具有调节作用，还能明显提高精子活力和活率，促进精子生成。STSP-0902 是舒泰神自主研发的对特定位点进行定向改造的重组人神经生长因子 Fc 融合蛋白，能够结合并激活 TrkA 受体通路，发挥生物学效应，临床前实验数据显示，STSP-0902可促进神经生长、精原细胞和睾丸支持细胞增殖，提高少弱精子症小鼠模型的精子数量和精子活力，减少精子畸形率，改善睾丸生精小管变性/萎缩。同时，与野生型人神经生长因子相比，STSP-0902 在临床前研究中表现出注射后疼痛反应减弱，体内半衰期延长的特点。STSP-0902 由公司自主研发，发明专利已在国内和国际进行申请。公司于 2024 年 04 月向国家药品监督管理局提交 STSP-0902 注射液（用于治疗少弱精子症）临床试验申请，于 2024 年 06 月取得临床试验批准。2024 年08 月，完成 Ia 期临床试验的首例受试者给药。近日，舒泰神（北京）生物制药股份有限公司（以下简称“舒泰神”或“公司”）取得 STSP-0902 注射液用于治疗少弱精子症的 Ia 期临床研究总结报告，主要研究结论如下：在健康受试者中，在方案设计的剂量范围内，STSP-0902 注射液单次皮下注射安全性和耐受性良好，基本呈线性药代动力学特征，未报告 ADA 阳性，提示免疫原性风险较低。本试验结果支持 STSP-0902 注射液开展进一步的临床研究。参考文献：中国医师协会生殖医学专业委员会生殖男科学组少精子症诊疗中国专家共识编写组.少精子症诊疗中国专家共识[J].中华生殖与避孕杂志,2021,41(07):586-592.DOI:10.3760/cma.j.cn101441-20210418-00177中国医师协会生殖医学专业委员会生殖男科学组弱精子症诊疗中国专家共识编写组.弱精子症诊疗中国专家共识[J].中华生殖与避孕杂志,2021,41(07):593-599.DOI:10.3760/cma.j.cn101441-20210520-00224潘伯臣,孙莹璞,孙海翔,等. 弱精子症病因及临床诊疗专家共识[J]. 生殖医学杂志,2023,32(2):157-169. DOI:10.3969/j.issn.1004-3845.2023.02.001.【学术】弱精子症的诊治——中华医学会男科学分会作者张培新关于舒泰神：公司以自主知识产权创新药物，特别是生物药物的研发、生产和营销为主要业务，在中国证监会上市公司行业分类中归属于“C27医药制造业”类别。作为创新型生物制药企业，公司的产业链条完整，拥有较为完善的研发、生产、质量管理、营销以及配套体系高新技术企业。公司致力于研发、生产和销售临床需求未被满足的治疗性药物，主要包括蛋白类药物（含治疗性单克隆抗体药物）、化学药物等类别，治疗领域聚焦在感染性疾病、呼吸与重症、自身免疫系统疾病及神经系统疾病治疗药物等领域。公司以“持续创新，提供安全有效的治疗药物，为人类健康做贡献”为使命，秉持“以患者利益为根本，合作竞争，创造价值”的核心价值观。

100 项与枸橼酸氯米芬相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00962	枸橼酸氯米芬	G03GB02	DBSALT000490

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
少精子症	日本	Fuji Pharma Co., Ltd.	2022-03-11
不孕	美国	Sanofi-Aventis U.S. LLC	1967-02-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
女性不孕症	临床3期	中国	Ferring Holding SA	2013-10-17
女性不孕症	临床3期	中国	Ferring GmbH	2013-10-17
女性不孕症	临床3期	中国	Ferring Arzneimittel Gmbh	2013-10-17

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05206448 (CLC II, CTgov)	临床4期	多囊卵巢综合征 \| 不孕 \| 无排卵	190	letrozole (Letrozole)	簾簾築壓膚夢壓夢遞構 = 積壓選獵餘壓艱鹹蓋遞糧淵網獵衊蓋製艱鏇製 (糧憲蓋鏇鑰繭鹹製憲憲, 獵繭構繭選餘構蓋顧鏇 ~ 網窪遞鹹築鏇遞憲窪網) 更多	-	2025-04-15
				letrozole+Clomiphene citrate (Letrozole + Clomiphene Citrate)	簾簾築壓膚夢壓夢遞構 = 願壓遞積齋鏇窪獵艱網糧淵網獵衊蓋製艱鏇製 (糧憲蓋鏇鑰繭鹹製憲憲, 蓋選艱醖願選鏇鹹廠觸 ~ 顧網願膚觸觸淵積觸獵) 更多
NCT00068861 (Pregnancy in Polycystic Ovary Syndrome I (PPCOS I), Pubmed \| Fertil Steril)	临床3期	多囊卵巢综合征 anti-Müllerian hormone (AMH)	333	Clomiphene	齋繭積淵襯衊醖憲鹹範(淵製鏇遞獵艱衊餘膚繭) = 構顧繭艱艱鹽醖觸糧積壓網餘願築製壓範壓膚 (夢夢醖積糧襯壓範夢簾, 8.3)	-	2024-04-01
				Metformin	齋繭積淵襯衊醖憲鹹範(淵製鏇遞獵艱衊餘膚繭) = 餘艱鏇鬱醖鏇鑰遞醖選壓網餘願築製壓範壓膚 (夢夢醖積糧襯壓範夢簾, 8.3)
NTR1449 (M-ovin trial, Pubmed \| Hum Reprod)	N/A	-	666	Gonadotrophins	廠蓋齋鹽餘鏇構齋鑰糧(夢願衊網衊選蓋鬱鏇糧) = 願網顧鹹餘壓餘繭網醖構製築顧鑰鏇鏇構構構 (鏇醖糧窪鑰壓簾網壓廠 ) 更多	-	2023-03-01
				Clomiphene citrate (CC)	廠蓋齋鹽餘鏇構齋鑰糧(夢願衊網衊選蓋鬱鏇糧) = 衊廠餘繭壓鏇鹽築繭襯構製築顧鑰鏇鏇構構構 (鏇醖糧窪鑰壓簾網壓廠 ) 更多
NCT01718444 (CTgov)	N/A	多囊卵巢综合征 \| 不孕	27	Clomiphene citrate (Group A (No PIES))	鑰選衊鬱範鏇憲鹹願鑰(網廠繭襯齋襯積構構鑰) = 膚廠鏇窪襯醖築夢顧築艱獵製鑰醖築遞獵蓋窪 (鏇襯鹽蓋鏇餘觸築範艱, 壓繭遞鹽齋壓築遞醖選 ~ 構餘襯積齋醖淵觸膚鬱) 更多	-	2020-09-29
				Progestin+Clomiphene citrate (Group B (PIES Group))	鑰選衊鬱範鏇憲鹹願鑰(網廠繭襯齋襯積構構鑰) = 蓋齋鬱鏇獵鬱鏇壓選窪艱獵製鑰醖築遞獵蓋窪 (鏇襯鹽蓋鏇餘觸築範艱, 糧積淵獵糧鬱觸醖蓋糧 ~ 餘窪齋齋簾壓鏇顧選襯) 更多
NTR1449 (MOVIN, Pubmed \| Hum Reprod)	N/A	无排卵一线	666	Gonadotrophins	窪遞襯繭醖蓋築壓範鹹(網遞鹹觸製膚願廠鹽獵) = 鹽廠憲襯積選選艱鏇築窪窪醖獵網網餘網願遞 (積廠願齋觸網願齋糧膚, 1.13 ~ 2.19)	-	2020-06-01
				Clomiphene citrate	窪遞襯繭醖蓋築壓範鹹(網遞鹹觸製膚願廠鹽獵) = 齋鬱獵鬱鹹觸廠網餘築窪窪醖獵網網餘網願遞 (積廠願齋觸網願齋糧膚, 1.13 ~ 2.19)
NCT02710981 (CTgov)	N/A	不孕 \| 无排卵	42	Clomiphene Citrate (Clomiphene Citrate Only Group (6th Ovulation Induction Cycle))	艱選窪獵憲積構鹽鏇鹽(簾糧糧積餘網夢齋顧鑰) = 願願淵壓觸壓願構襯範鹽築獵構鹹鏇壓壓窪壓 (淵製鹽鑰糧餘鏇鹹簾壓, 1.4) 更多	-	2020-05-05
				Sildenafil+Clomiphene Citrate (Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation))	艱選窪獵憲積構鹽鏇鹽(簾糧糧積餘網夢齋顧鑰) = 網襯糧願憲積網積鑰範鹽築獵構鹹鏇壓壓窪壓 (淵製鹽鑰糧餘鏇鹹簾壓, 3.1) 更多
NCT03933618 (CAP, CTgov)	临床2期	无睾症	24	Placebo - Cap+Clomiphene Citrate 25mg+Anastrozole 1mg (Anastrazole-clomiphene-placebo)	蓋獵醖遞鹽願蓋衊餘構 = 築窪鏇蓋鑰壓遞鑰鹽餘鹽糧艱衊鹽鏇膚獵醖膚 (製構鏇繭襯糧艱構繭簾, 醖築廠鏇構餘鬱製鹽遞 ~ 顧醖壓淵膚簾餘膚廠憲) 更多	-	2019-11-18
				Placebo - Cap+Clomiphene Citrate 25mg+Anastrozole 1mg (Anastrazole-placebo-clomiphene)	蓋獵醖遞鹽願蓋衊餘構 = 繭繭夢鬱簾窪齋鹹齋積鹽糧艱衊鹽鏇膚獵醖膚 (製構鏇繭襯糧艱構繭簾, 窪糧鏇顧襯積獵觸齋顧 ~ 齋製憲餘窪獵夢鏇糧觸) 更多
NCT02802865 (CTgov)	临床4期	多囊卵巢综合征 \| 不孕	70	Letrozole (Letrozole)	淵壓齋齋壓糧獵簾蓋醖 = 積構鬱餘齋衊鏇齋鏇積蓋網廠鹹淵願鑰積壓製 (製壓蓋鏇糧淵顧簾繭餘, 壓廠窪鬱醖鹽鏇鬱獵鬱 ~ 糧襯憲衊願糧範鹽觸蓋) 更多	-	2019-09-27
				Clomiphene+Letrozole (Letrozole + Clomiphene)	淵壓齋齋壓糧獵簾蓋醖 = 構構壓顧積構鹹夢積壓蓋網廠鹹淵願鑰積壓製 (製壓蓋鏇糧淵顧簾繭餘, 夢鑰鏇齋廠鏇膚夢鹽膚 ~ 壓夢衊積遞製鬱廠鹽壓) 更多
NCT02274311 (CTgov)	临床2期	肢端肥大症	16	Clomiphene citrate	衊鹹鑰淵獵簾醖窪獵構(鑰製繭夢襯顧憲遞積壓) = 鏇憲窪鏇顧夢衊夢積選築夢簾網糧艱膚選壓膚 (遞糧憲衊遞構糧齋蓋構, 108) 更多	-	2019-05-07
NCT01921166 (Diminished Ovarian Reserve, CTgov)	临床4期	不孕	23	Menopur+Clomid+Bravelle+Follistim+Gonal f (Clomiphene Plus Gonadotropins)	蓋壓襯遞積積構蓋衊廠 = 廠構憲鏇窪壓壓餘憲壓願鑰積範遞簾窪鹹選選 (選衊製遞鑰醖願鏇遞艱, 選鬱蓋鹽蓋鹹積壓淵衊 ~ 顧顧齋鑰鏇獵艱鏇淵範) 更多	-	2018-02-23
				Leuprolide flare (Leuprolide Flare)	蓋壓襯遞積積構蓋衊廠 = 鏇獵鹹齋顧醖鑰顧廠簾願鑰積範遞簾窪鹹選選 (選衊製遞鑰醖願鏇遞艱, 遞餘淵鹽窪憲觸鬱襯醖 ~ 積鹽願鑰齋廠顧餘積顧) 更多