更新于：2024-09-21
Choriogonadotropin alfa
重组人绒促性素
更新于：2024-09-21
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (1973-03-05), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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序列信息
Sequence Code 3246
来源: *****
Sequence Code 51997
来源: *****
关联
39
项与 重组人绒促性素 相关的临床试验A Phase I Clinical Trial to Compare the Pharmacokinetics, Safety and Immunogenicity of SJ04 and Ovidrel® in Healthy Female Subjects in China
To compare the effect of single versus double dose of recombinant human chorionic gonadotropin on final oocyte maturation in long agonist in vitro fertilisation cycles- A Prospective Randomized Controlled Study - NIL
Can Biotin Supplementation be Used to Mask hCG Abuse?
100 项与 重组人绒促性素 相关的临床结果
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100 项与 重组人绒促性素 相关的转化医学
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100 项与 重组人绒促性素 相关的专利（医药）
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172
项与 重组人绒促性素 相关的文献（医药）2024-07-01Reproductive biomedicine online
Modified natural cycle allows a window of 7 days for frozen embryo transfer planning
Article
作者: Santos-Ribeiro, Samuel ; Kohls, Graciela ; Soares, Sergio Reis ; Garcia-Velasco, Juan A ; Alonso-Mayo, Carlos
RESEARCH QUESTION:
Should ovulation be triggered in a modified natural cycle (mNC) with recombinant human chorionic gonadotrophin (rHCG) as soon as a mean follicle diameter of 17 mm is visible, or is more flexible planning possible?
DESIGN:
This multicentre, retrospective, observational study of 3087 single frozen blastocyst transfers in mNC was carried out between January 2020 and September 2022. The inclusion criteria included endometrial thickness ≥7 mm and serum progesterone <1.5 ng/ml. The main outcome was ongoing pregnancy rate. Secondary end-points were pregnancy rate, implantation rate, clinical pregnancy rate and miscarriage rate. The mean follicle size at triggering was stratified into three groups (13.0-15.9, 16.0-18.9 and 19.0-22 mm).
RESULTS:
The baseline characteristics between the groups did not vary significantly for age, body mass index and the donor's age for egg donation. No differences were found in pregnancy rate (64.5%, 60.2% and 57.4%; P = 0.19), clinical pregnancy rate (60.5%, 52.8% and 50.6%; P = 0.10), implantation rate (62.10%, 52.9% and 51.0%; P = 0.05) or miscarriage rate (15.0%, 22.2%; and 25.0%; P = 0.11). Although ongoing pregnancy rate (54.9%, 46.8% and 43.1%; P = 0.02) varied significantly in the univariable analysis, it was no longer significant after adjustment for the use of preimplantation genetic testing for aneuploidies and egg donation.
CONCLUSIONS:
The findings showed rHCG could be flexibly administered with a mean follicle size between 13 and 22 mm as long as adequate endometrial characteristics are met, and serum progesterone is <1.5 ng/ml. Considering the follicular growth rate of 1-1.5 mm/day, this approach could allow a flexibility for FET scheduling of 6-7 days, simplifying mNC FET planning in clinical practice.
2024-07-01Clinical endocrinology
Single and multi‐dose pharmacology of recombinant and urinary human chorionic gonadotrophin in men
Article
作者: Idan, Amanda ; Handelsman, David J ; Desai, Reena ; Grainger, Janelle ; Goebel, Catrin ; Kouzios, Dorothy ; Jayadev, Venna ; Sleiman, Sue ; Conway, Ann J ; Savkovic, Sasha
Abstract:
Objective:
Human choriogonadotrophin (hCG) treatment of gonadotrophin‐deficient infertile men uses hCG of urinary (uhCG) or recombinant (rhCG) origin, but these treatments have not been compared nor are there studies defining rhCG dosing in men.
Design:
hCG products were studied in randomized cross‐over single‐dose studies of standard (Study 1, 1500 IU and 62.5 µg, respectively) or high (Study 2, 5000 IU and 250 µg) dose and a multi‐dose population pharmacology study of hCG use.
Participants:
Eight (Study 1) and seven (Study 2) volunteers in cross‐over and 52 gonadotrophin‐deficient men in the multi‐dose study
Measurements:
In cross‐over studies, serum testosterone (T), dihydrotestosterone (DHT) and estradiol by liquid chromatography‐mass spectrometry (LCMS) and serum hCG, LH, FSH, SHBG and T (observational study) by immunoassays.
Results:
After standard and high‐dose injection, serum hCG and testosterone responses had similar timing and peak concentrations except for a mildly lower early (<48 h) serum testosterone with uhCG. In the multi‐dosing study, both hCGs had similar pharmacokinetics (pooled half‐life 5.8 days, p < .001), while serum testosterone concentrations were stable after injection and did not differ between hCG products. Bench testing verified that 20% of pens from 4/10 individuals were used inappropriately.
Conclusions:
Although hCG pharmacokinetics are not formally bioequivalent, the similar pharmacodynamic effects on serum testosterone indicate that at the doses tested both hCGs provide comparable clinical effects. The starting dose of rhCG for treating gonadotrophin‐deficient men should be 62.5 µg (6 clicks) of the rhCG pen.
2024-07-01HUMAN REPRODUCTION
Circadian serum progesterone variations on the day of frozen embryo transfer in a modified natural cycle protocol
Article
作者: Aktoz, F ; Tournaye, H ; Niero, M ; Roelens, C ; Blockeel, C ; Mackens, S ; De Munck, N ; Loreti, S
Abstract:
STUDY QUESTION:
Is there a circadian variation of serum progesterone (P) on the day of frozen embryo transfer (FET) in a modified natural cycle (mNC)?
SUMMARY ANSWER:
There is a statistically significant diurnal variation of serum P on the day of a FET in an mNC protocol.
WHAT IS KNOWN ALREADY:
In recent years, the proportion of FET cycles has increased dramatically. To further optimize pregnancy outcomes after FET, recent studies have focused on serum luteal P levels in both natural and artificially prepared FET cycles. Despite the different cut-off values proposed to define low serum P in the NC, it is generally accepted that lower serum P values (<10 ng/ml) around the day of FET are associated with negative reproductive outcomes. However, a single serum P measurement is not reliable given that P levels are prone to diurnal fluctuations and are impacted by patients’ characteristics.
STUDY DESIGN, SIZE, DURATION:
A prospective cohort study was conducted in a single university-affiliated fertility center, including 22 patients performing a single blastocyst mNC-FET from August 2022 to August 2023. Serum P levels were measured on the day of transfer at 08:00h, 12:00h, 16:00h, and 20:00h. Differences between P levels were compared using the Wilcoxon signed-rank test. The sample size was calculated to detect a difference of 15% between the first and last P measurements with a 5% false-positive rate and a 95% CI.
PARTICIPANTS/MATERIALS, SETTING, METHODS:
Patients with a normal BMI, between 18 and 40 years old, without uterine diseases were eligible. Patients utilizing donated oocytes were excluded. The mNC-FET protocol involved monitoring the normal ovarian cycle and triggering ovulation with an injection of 250 μg of choriogonadotropin alfa when a pre-ovulatory follicle (16–20 mm diameter) was visualized. The blastocyst was transferred seven days later. The patients were not supplemented with exogenous P at any time before the day of the FET.
MAIN RESULTS AND THE ROLE OF CHANCE:
The mean age and BMI of the study population were 33.6 ± 3.8 years and 22.7 ± 1.8 kg/m2, respectively. Mean P values at 08:00h, 12:00h, 16:00h, and 20:00h were 14.6 ± 4.5, 14.7 ± 4.1, 12.9 ± 3.5, and 14.6 ± 4.3 ng/ml, respectively. The mean P levels at 16:00h were significantly lower compared to all other time points (P < 0.05: P = 0.007 between P at 8:00h and 16:00h; P = 0.003 between P at 12:00h and 16:00h; P = 0.007 between P at 16:00h and 20:00h). No statistically significant difference was observed between P values at the other time points (P > 0.05: P = 0.88 between P at 8:00h and 12:00h; P = 0.96 between P at 8:00h and 20:00h; P = 0.83 between P at 12:00h and 20:00h).
LIMITATIONS, REASONS FOR CAUTION:
The study’s limitations include the small sample size that may cause a bias when the results are extrapolated to a larger subfertile population undergoing mNC-FET. Ideally, larger prospective trials including a more heterogeneous patient population would be necessary to validate our findings.
WIDER IMPLICATIONS OF THE FINDINGS:
The current study demonstrates the existence of a diurnal fluctuation of serum P on the day of mNC-FET highlighting the importance of a standardized time point for its measurement. This is especially important for considering clinical actions, such as additional exogenous P supplementation, when encountering P values lower than 10 ng/ml on the day of FET.
STUDY FUNDING/COMPETING INTEREST(S):
No funding was obtained for the study. The authors have no conflicts of interest to declare regarding the content of the study.
TRIAL REGISTRATION NUMBER:
NCT05511272.
100 项与 重组人绒促性素 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 女性不孕症 | 欧盟 | 2001-02-02 | |
| 女性不孕症 | 冰岛 | 2001-02-02 | |
| 女性不孕症 | 列支敦士登 | 2001-02-02 | |
| 女性不孕症 | 挪威 | 2001-02-02 | |
| 不孕 | 美国 | 2000-09-20 | |
| 性腺机能减退 | 美国 | 1973-03-05 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 无排卵 | 临床3期 | 日本 | 2012-09-01 | |
| 功能障碍 | 临床3期 | 日本 | 2012-09-01 | |
| 下丘脑疾病 | 临床3期 | 日本 | 2012-09-01 | |
| 多囊卵巢综合征 | 临床3期 | 日本 | 2012-09-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 166 | (Gonal-f 75 IU) | 顧觸餘蓋夢觸廠襯衊壓(顧觸製製製衊醖鏇蓋襯) = 襯襯遞積簾願襯觸鹽積 夢鬱鏇膚獵膚膚築糧網 (淵構壓夢膚淵鑰餘壓構, 膚鹽鑰顧壓齋鏇鹹淵衊 ~ 顧顧築艱鏇獵網鹹齋糧) 更多 | - | 2018-03-30 | ||
(Gonal-f 112.5 IU) | 顧觸餘蓋夢觸廠襯衊壓(顧觸製製製衊醖鏇蓋襯) = 衊蓋築範鬱窪蓋襯構願 夢鬱鏇膚獵膚膚築糧網 (淵構壓夢膚淵鑰餘壓構, 憲蓋蓋簾簾簾衊鬱餘壓 ~ 鏇構壓鏇遞選醖淵觸觸) 更多 | ||||||
临床3期 | 81 | 獵鹹蓋艱積壓鹽簾鹽膚(製餘製築廠鏇築襯夢憲) = 遞網鏇鏇壓鏇夢鏇壓齋 壓網衊簾壓網繭遞獵齋 (顧糧構構餘鹹鏇鏇襯簾, 壓築淵鬱觸願製衊餘獵 ~ 廠襯獵積膚顧獵遞膚鹽) 更多 | - | 2016-01-07 | |||
临床3期 | 202 | (Gonal-f® Plus Pergoveris®) | 壓淵艱襯鬱艱範願醖願(夢鏇窪鹽廠窪鹽膚選醖) = 鹽壓範鏇遞顧廠築夢鏇 壓衊網襯積鏇夢壓糧繭 (選艱選鏇鑰淵窪廠糧鏇, 鹹蓋構鑰鹽觸願製遞艱 ~ 夢襯蓋觸艱簾獵鹽醖齋) 更多 | - | 2014-02-24 | ||
壓淵艱襯鬱艱範願醖願(夢鏇窪鹽廠窪鹽膚選醖) = 觸遞繭壓餘範選積窪鏇 壓衊網襯積鏇夢壓糧繭 (選艱選鏇鑰淵窪廠糧鏇, 簾簾鹹壓積鬱齋鏇願膚 ~ 鏇淵齋衊顧醖築廠願網) 更多 | |||||||
临床4期 | 11 | Recombinant human chorionic gonadotropin (r-hCG)+Luveris® 75 IU+Recombinant human follicle stimulating hormone (r-hFSH) (Luveris® 75 IU) | 築淵窪選襯鏇築廠選構(鬱繭壓衊齋顧膚遞衊齋) = 製鑰壓鏇鑰製膚觸廠鬱 襯獵遞鑰鹽衊廠醖製壓 (廠網窪鬱蓋遞鑰鑰窪衊, 醖構鏇選簾憲餘獵網壓 ~ 願襯範襯鬱廠襯觸繭鏇) 更多 | - | 2013-07-12 | ||
Recombinant human chorionic gonadotropin (r-hCG)+Luveris® 25 IU+Recombinant human follicle stimulating hormone (r-hFSH) (Luveris® 25 IU) | 築淵窪選襯鏇築廠選構(鬱繭壓衊齋顧膚遞衊齋) = 廠壓顧繭襯簾鏇遞遞蓋 襯獵遞鑰鹽衊廠醖製壓 (廠網窪鬱蓋遞鑰鑰窪衊, 簾廠鑰鏇齋顧選繭積願 ~ 顧艱餘鏇網醖繭製廠餘) 更多 | ||||||
临床3期 | 25 | hCG (PCOS) | 淵窪積簾壓鹽艱鏇鑰顧(選窪鹽鬱蓋獵壓壓願衊) = 餘膚鹹襯觸製衊壓繭糧 鬱窪窪鬱範壓襯簾鹽積 (夢築遞鑰構齋窪夢遞選, 願衊鹹窪繭簾觸憲鹽憲 ~ 築糧夢選淵襯糧繭繭鏇) 更多 | - | 2013-01-29 | ||
hCG (Normal) | 淵窪積簾壓鹽艱鏇鑰顧(選窪鹽鬱蓋獵壓壓願衊) = 顧觸糧壓膚鏇窪網簾餘 鬱窪窪鬱範壓襯簾鹽積 (夢築遞鑰構齋窪夢遞選, 簾蓋獵艱獵構鏇憲襯鹽 ~ 鹹鑰鬱網淵餘選鑰廠鹽) 更多 | ||||||
临床4期 | 27 | 範獵製網餘憲鹽繭範衊(膚遞遞鑰繭鏇憲餘繭願) = 繭築構廠範襯顧顧願淵 遞鏇顧淵構積餘簾觸艱 (齋簾願壓餘廠襯蓋廠壓, 糧顧糧壓鬱觸鹹襯蓋鑰 ~ 鏇餘鑰獵顧齋齋壓鏇願) 更多 | - | 2012-11-14 | |||
構膚獵願簾製鏇鹹遞醖(獵獵襯窪製鹹顧積鏇鏇) = 願鹹繭積艱鬱夢醖鹹衊 膚壓夢膚顧廠繭壓齋願 (鏇遞遞範遞憲醖壓鹹繭, 糧蓋鹹膚鬱艱選鬱鹹壓 ~ 蓋廠憲積艱衊鬱積襯淵) 更多 |
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