Merional(Merional) - 药物靶点：LHCGR_在研适应症：无排卵_专利_临床

概要

基本信息

药物类型

激素

别名

human menopausal gonadotropin( IBSA Institut Biochimique SA)

靶点

LHCGR

作用机制

LHCGR激动剂(促黄体激素/绒毛膜促性腺激素受体激动剂)

治疗领域

内分泌与代谢疾病泌尿生殖系统疾病

在研适应症

无排卵

非在研适应症

多囊卵巢综合征

原研机构

IBSA Institut Biochimique SA

在研机构

Ibsa Farmaceutici Italia Srl

非在研机构

Saudi German Hospitals Group

最高研发阶段批准上市

首次获批日期

(2009-03-02),

无排卵

最高研发阶段(中国)-

特殊审评-

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关联

10

项与 Merional 相关的临床试验

NCT04754243

/ Recruiting临床4期IIT

A Higher Ovulation and Pregnancy Rates in Patients With Unexplained Infertility After Application of ANTIUI Protocol: A Randomized Multicenter Controlled Study

The new protocol ANTIUI provides good results regarding ovulation and pregnancy rates in patients with unexplained infertility

开始日期2021-03-01

申办/合作机构

Tanta University

IRCT20151013024512N7

/ Completed临床2期IIT

A comparison of the effect of intraovarian injection of autologous platelet rich plasma (PRP) versus PRP plus gonadotropin and gonadotropin alone on ovarian rejuvenation in patients with diminished ovarian reserve

开始日期2021-02-15

申办/合作机构-

NCT04537078

/ Completed临床3期IIT

Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders

The worldwide prevalence of primary and secondary infertility is estimated at
2% and 10.5%, respectively, among women aged 20-44 years and attempting to conceive. Poor ovarian responders (PORs) involve 9-24% of patients undergoing in-vitro fertilization (IVF). proper tailoring of the ovarian stimulation protocol in order to maximize the number of oocytes collected represents a crucial step for them to eventually conceive.
Recent evidence indicates that in the same menstrual cycle, there are multiple follicular recruitment waves. This coincides with the theory that folliculogenesis occurs in a wave-like fashion. Thus, within a single menstrual cycle, there can theoretically be multiple opportunities for a clinician to collect oocytes, as opposed to the conventional single cohort of antral follicles during the follicular phase.
Utilizing this concept, clinicians have been attempting to retrieve oocytes from poor responders using both the follicular-phase stimulation (FPS) and the luteal-phase stimulation (LPS) protocols to increase the number of oocytes collected shorter within shorter period of time. By increasing the number of the retrieved oocytes collected, a better clinical can be assured since there is a clear relationship between the number of oocytes collected and live birth rates across all female age groups.
which protocol is the most effective remains controversial and the efficacy of PPOS in POR compared with that of conventional protocols is unclear.

开始日期2020-09-01

申办/合作机构-

100 项与 Merional 相关的临床结果

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100 项与 Merional 相关的转化医学

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100 项与 Merional 相关的专利（医药）

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757

项与 Merional 相关的文献（医药）

2024-12-31·Ceska Gynekologie-Czech Gynaecology

Comparing highly purified human menopausal gonadotropin and recombinant follicle stimulating hormone in poor ovarian reserve patients undergoing intracytoplasmic sperm injection

Article

作者: Akgun, Humeyra ; Gunenc, Oguzhan ; Dogru, Sukran ; Tutar, Mahmut Sami ; Korucu, Dilay Gok

Objective: We aimed to compare highly purified human menopausal gonadotropin (hp-hMG) and recombinant follicle stimulating hormone (rFSH) in short antagonist in vitro fertilization (IVF) cycles of patients with poor ovarian reserve (POR). Limited research exists on this comparison in short antagonist cycles for this patient group. Materials and methods: This retrospective cohort study involved 165 POR patients aged 18–45 years who underwent IVF between 2018 and 2022. Patients were divided into two groups based on their GnRH antagonist protocol: hp-hMG (group 1 = 72) and rFSH (group 2 = 93). We compared pregnancy outcomes, number of oocytes collected, mature oocytes retrieved, mean fertilized oocytes, top quality embryos transferred, and serum estradiol (E2) and progesterone (P) levels on human chorionic gonadotropin (hCG) administration day. Results: No significant differences were found in E2 and P levels on hCG trigger day, endometrial thickness on transfer day, stimulation duration, total oocyte number, and mature oocyte number (P > 0.05). The total gonadotropin dose was significantly higher in the rFSH group (P < 0.001). The number of top-quality embryos transferred and clinical pregnancy and live birth rates did not diff er significantly between groups (P = 0.320; P = 0.310; P = 0.652; and P = 0.662, resp.). Conclusion: Neither hp-hMG nor rFSH showed superiority in patients with POR, indicating similar effectiveness in this population. Key words: highly purified human menopausal gonadotropin – in vitro fertilization – live birth – poor ovarian reserve – recombinant follicle stimulating hormone

2024-12-01·Iranian biomedical journal

25th National and 11th International Annual Congress on Research and Technology of Iranian Medical Sciences Students, Urmia, Iran, 5-7 September, 2024

Article

作者: Joghatayi, Farzaneh ; Afzaljavan, Fahimeh ; Morovatdar, Negar ; Afiat, Maliheh ; Pousti, Navid ; Khadem Ghaebi, Nayyereh

Introduction:

Infertility is a severe challenge for most health systems. One of the medications recently used for ovulation induction is letrozole, applied either alone or in combination with gonadotropin. The present study was conducted to compare ovulation induction in infertile polycystic ovarian syndrome (PCOS) women candidates of intrauterine insemination (IUI) who were resistant to letrozole by two regimens: single-drug stair step letrozole vs. combined letrozole plus human menopausal gonadotropin.

Methods and Materials:

In this parallel randomized clinical trial, 60 infertile women with PCOS, candidates for intrauterine insemination, admitted to Milad Infertility Center at Imam Reza Hospital, Mashhad, Iran, were randomly assigned into two groups. The intervention group received 5 mg of letrozole for five days from menstruation day 3 and 7.5 mg of letrozole for another five days if dominant follicles were not observed on days 14-19. Control cases received letrozole (5 mg) from day 3 of the cycle for five days plus Cinnal-f® (75 international units subcutaneously daily) on days 8 and 9. They received another dose of Cinnal-f® if the dominant follicle was not observed on days 10-12 of the cycle. In the case of detecting dominant follicles, 5000 units of intramuscular hCG were prescribed, and 36 hours later, the patients underwent IUI. The outcomes were considered, and data were analyzed using SPSS.

Results:

Almost 70% of the stair-step letrozole group and 53.2% in the combined medication had a dominant follicle (p = 0.12), mainly observed after day 14 in the stair-step letrozole group and during days 10-14 in the letrozole/gonadotropin group (p = 0.001). The positive beta-hCG level was significantly higher in the stair-step letrozole group (23.3%) than in the letrozole/gonadotropin group (13.3%). The clinical pregnancy and gestations of 20 weeks or beyond (ongoing pregnancy) were 16.66% and 10% in the stair-step letrozole and letrozole/gonadotropin groups, respectively (p = 0.03).

Conclusion and Discussion:

Our study found similar frequencies of dominant follicles between the stair-step letrozole and letrozole/ gonadotropin groups and a significantly higher frequency of chemical pregnancy (positive beta-hCG) and clinical and ongoing pregnancy in the stair-step letrozole group. As an easy and acceptable method for patients, this protocol can be a suitable alternative for ovulation induction.

2024-10-01·Journal of human reproductive sciences

Evaluation of Predictors of Response to Ovulation Induction Using Letrozole in Women with Polycystic Ovary Syndrome: A Prospective Cohort Study

Article

作者: Jayraj, Aarthi K. ; Kalaivani, Mani ; Malhotra, Neena ; Sati, Hem Chandra ; Sharma, Mona ; Kumari, Archana ; Mahey, Reeta ; Tholiya, Shanti

ABSTRACT:

Background::

Ovulation induction (OI) in patients with polycystic ovary syndrome (PCOS) remains challenging, and several biomarkers have been evaluated for their ability to predict ovulation. The predictive ability of candidate biomarkers, particularly with letrozole-based therapy in infertile PCOS women, remains inconclusive as it is yet to be evaluated in a prospective study.

Aim::

To assess the role of anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH), luteinising hormone (LH)/FSH ratio, testosterone and free androgen index (FAI) as predictors of ovarian response to letrozole-based OI therapy during OI cycles in infertile women with PCOS from North India.

Settings and Design::

A prospective cohort study was conducted in a tertiary care hospital in north India.

Materials and Methods::

The study enrolled 80 infertile women with PCOS, diagnosed according to the Rotterdam criteria. OI was conducted using letrozole with or without human menopausal gonadotropin. Baseline endocrine and metabolic parameters, including serum AMH, FSH, LH, testosterone and FAI levels, were measured using ELISA or chemiluminescence methods on day 2 of the menstrual cycle. Follicular response to OI was monitored by transvaginal ultrasonography.

Statistical Analysis Used::

Descriptive and inferential statistical analyses were conducted, including Mann–Whitney, Kruskal–Wallis, Independent t-test, analysis of variance, Fisher’s exact test and receiver operating characteristic curve analysis. Data were processed using Microsoft Excel and analysed with SPSS software, version 25.0. P < 0.05 was considered statistically significant.

Results::

Of 80 women enrolled, 74 responded to letrozole-based OI, while six were non-responders. Body mass index (BMI), serum testosterone and pre-treatment AMH levels significantly correlated with follicular response, with higher values linked to reduced responsiveness. The likelihood ratio+ (95% confidence interval) was 3.32 (2.45–5.06) for AMH, 1.97 (1.03–3.78) for BMI and 1.93 (1.22–3.08) for testosterone. The odds ratio for AMH was 2.88 (1.01–8.21) and 1.25 (1.02–1.53) for BMI. An AMH cut-off of ≤16.43 ng/mL predicted ovarian response with an AUC of 0.88.

Conclusions::

Pre-treatment AMH levels, along with BMI and serum testosterone, are significant predictors of ovarian response to letrozole-based OI in infertile women with PCOS.

100 项与 Merional 相关的药物交易

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研发状态

批准上市

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适应症	国家/地区	公司	日期
无排卵	-	Ibsa Farmaceutici Italia Srl	2009-03-02

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适应症	最高研发状态	国家/地区	公司	日期
多囊卵巢综合征	临床3期	沙特阿拉伯	Saudi German Hospitals Group	2019-04-01

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临床结果

适应症

分期

评价

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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


ESPE2022	N/A	性腺机能减退	9	Testosterone	夢鏇網膚鏇鑰醖網鑰鹹(積淵構鹹積構壓憲願網) = 遞壓糧壓壓淵觸遞衊鑰鑰簾獵糧鏇顧製築艱積 (繭糧築鏇壓蓋醖範鹹簾 )	-	2022-09-15
ESPE2022	N/A	软骨-头发发育不良	72	gonadotropin	鹹憲獵網選糧構膚夢獵(築淵膚繭觸糧憲顧壓網) = 構鹽遞憲憲鹹糧淵鑰膚夢餘製遞選願憲壓壓範 (簾壓鏇窪鹹範繭鏇積夢, 48) 更多	-	2022-09-15
				gonadotropin	鹹憲獵網選糧構膚夢獵(築淵膚繭觸糧憲顧壓網) = 蓋鑰構淵餘鬱積製積衊夢餘製遞選願憲壓壓範 (簾壓鏇窪鹹範繭鏇積夢, 54) 更多
NCT04537078 (CTgov)	临床3期	女性不孕症	90	Combined Oral Contraceptive+Decapeptyl+Cyclo-Progynova+progesterone+Gonadotropin+Duphaston (the Progestin Primed Double Stimulation Group)	鑰艱鏇選顧餘範憲範願(鹽鹽鑰繭積鏇襯鬱遞製) = 築憲構構簾鏇鹽製餘窪鏇選選構鹹壓醖蓋願窪 (繭憲齋蓋壓簾齋醖鹽衊, 獵蓋網積壓襯積壓齋獵 ~ 衊醖鏇製範願餘衊糧築) 更多	-	2022-02-17
				Combined Oral Contraceptive+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone+Chorionic Gonadotropin+Gonadotropin (the Flexible GnRh Antagonist)	選鏇製鏇獵蓋膚製範鏇(獵蓋顧憲壓壓糧餘餘鑰) = 顧襯選憲鹹鹹衊衊範淵醖鏇顧觸齋醖醖鹽醖齋 (鬱顧蓋簾獵憲範構壓壓, 繭簾鹹願齋齋築憲網鬱 ~ 築餘築鏇獵糧鹹製衊壓) 更多
ESPE2021	N/A	继发性睾丸衰竭 testosterone \| AMH \| Inhibin B	-	Continuous administration of recombinant gonadotropins by pump	繭顧鬱醖願構網衊廠繭(艱簾憲築願糧網觸艱壓) = 餘積醖網網夢範艱網顧繭築膚餘繭襯艱鏇顧構 (憲襯窪壓廠襯鬱蓋鬱遞 ) 更多	积极	2021-09-22
				Subcutaneous injections of recombinant gonadotropins	繭顧鬱醖願構網衊廠繭(艱簾憲築願糧網觸艱壓) = 製襯鑰築淵繭鏇構觸觸繭築膚餘繭襯艱鏇顧構 (憲襯窪壓廠襯鬱蓋鬱遞 ) 更多
ESPE2018	N/A	卡尔曼综合征	43	HCG/HMG	繭簾願齋網憲鹹積築簾(鑰廠願蓋獵蓋襯鬱壓獵) = 觸憲醖醖夢鑰範餘鹽遞鬱築憲襯獵選積顧餘構 (鬱淵壓簾積鬱窪襯糧鹹 ) 更多	积极	2018-09-27
				GnRH	繭簾願齋網憲鹹積築簾(鑰廠願蓋獵蓋襯鬱壓獵) = 餘簾憲範願鬱鬱製齋構鬱築憲襯獵選積顧餘構 (鬱淵壓簾積鬱窪襯糧鹹 ) 更多