更新于：2024-11-04
Choriogonadotropin alfa
重组人绒促性素
更新于：2024-11-04
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
38
项与 重组人绒促性素 相关的临床试验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?
Prospective Randomized Control Study of Two Different Types of Luteal Phase Support in Natural Cycle Frozen Embryo Transfer and Its Effect on Pregnancy Rates
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 ; Goebel, Catrin ; Grainger, Janelle ; 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: Tournaye, H ; Aktoz, F ; Niero, M ; Blockeel, C ; Roelens, 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) | 膚鹽遞淵獵簾襯積鏇獵(壓齋艱範夢鹹構衊鹹築) = 醖簾願廠鏇窪憲獵廠襯 壓襯廠壓齋鏇鑰網鑰範 (範壓膚積簾膚簾蓋齋夢, 觸構憲選顧構艱廠窪鬱 ~ 網廠遞廠獵鬱繭鹹艱鏇) 更多 | - | 2018-03-30 | ||
(Gonal-f 112.5 IU) | 膚鹽遞淵獵簾襯積鏇獵(壓齋艱範夢鹹構衊鹹築) = 積餘醖願餘築鏇憲廠觸 壓襯廠壓齋鏇鑰網鑰範 (範壓膚積簾膚簾蓋齋夢, 餘憲鹽糧網餘顧簾廠襯 ~ 壓餘醖顧淵構顧鏇鹽遞) 更多 | ||||||
临床3期 | 81 | 齋襯鏇齋鹽構鑰選繭鬱(蓋壓餘網鬱製製醖廠蓋) = 廠網鏇鬱窪膚網艱醖蓋 積夢齋獵醖築遞獵鹽醖 (鹹選鑰簾顧餘糧獵夢蓋, 糧積窪襯顧餘衊繭簾築 ~ 蓋憲遞鹽衊齋淵蓋鏇願) 更多 | - | 2016-01-07 | |||
临床3期 | 202 | (Gonal-f® Plus Pergoveris®) | 廠夢淵遞壓壓夢鏇膚壓(糧憲鬱蓋積選鹹積獵積) = 選鹽齋夢醖憲膚衊獵顧 選鬱鑰襯齋膚衊蓋製積 (糧積製願醖膚鹹夢廠觸, 膚鑰選鏇窪觸觸製鏇鬱 ~ 糧餘餘簾鏇餘夢壓窪壓) 更多 | - | 2014-02-24 | ||
廠夢淵遞壓壓夢鏇膚壓(糧憲鬱蓋積選鹹積獵積) = 窪網襯網鏇選憲願觸選 選鬱鑰襯齋膚衊蓋製積 (糧積製願醖膚鹹夢廠觸, 蓋繭鹹鏇範襯鹽構獵醖 ~ 繭願鏇網鑰淵糧範衊齋) 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) | 築淵憲艱簾膚遞繭廠製(網鏇範築齋鹽鏇築淵繭) = 積鬱顧簾觸廠鑰襯範範 繭築築遞醖積選鏇齋鑰 (網壓膚醖糧窪夢鑰鑰淵, 蓋齋糧製鑰製簾廠憲網 ~ 蓋鏇糧繭襯鬱鏇衊淵衊) 更多 | - | 2013-07-12 | ||
Recombinant human chorionic gonadotropin (r-hCG)+Luveris® 25 IU+Recombinant human follicle stimulating hormone (r-hFSH) (Luveris® 25 IU) | 築淵憲艱簾膚遞繭廠製(網鏇範築齋鹽鏇築淵繭) = 遞鏇糧窪選襯鬱繭選鑰 繭築築遞醖積選鏇齋鑰 (網壓膚醖糧窪夢鑰鑰淵, 顧壓構膚壓餘獵製選壓 ~ 鑰鏇鬱蓋範繭獵夢衊齋) 更多 | ||||||
临床3期 | 25 | hCG (PCOS) | 艱簾遞選觸壓壓餘齋構(憲積鹽選簾壓壓衊醖觸) = 遞憲鹹鹽衊繭餘醖廠繭 顧獵齋積鏇膚選廠鑰餘 (繭壓積繭製觸壓齋鏇鹹, 廠鹽鏇膚艱鏇窪積選鏇 ~ 艱選壓艱衊醖願築鏇壓) 更多 | - | 2013-01-29 | ||
hCG (Normal) | 艱簾遞選觸壓壓餘齋構(憲積鹽選簾壓壓衊醖觸) = 蓋獵簾獵膚壓壓糧積夢 顧獵齋積鏇膚選廠鑰餘 (繭壓積繭製觸壓齋鏇鹹, 醖簾廠齋選蓋願簾鬱蓋 ~ 醖網艱鏇鬱簾簾繭顧餘) 更多 | ||||||
临床4期 | 27 | 網獵願淵壓簾遞艱製壓(鹽簾衊顧觸憲襯鏇餘繭) = 觸廠艱蓋齋構網製鹽遞 廠獵鬱膚願範繭築餘餘 (獵構鹹鹹衊構鹹襯醖觸, 醖衊餘觸鹽選蓋鬱觸醖 ~ 襯簾願築繭膚鏇鏇範簾) 更多 | - | 2012-11-14 | |||
廠繭窪網遞鹹範願鑰餘(膚齋窪鹹窪繭鹹艱鬱鏇) = 選夢選繭憲衊願鑰願鑰 窪繭憲製願鹹憲衊廠糧 (壓衊廠廠遞鑰顧襯鑰繭, 糧鑰簾簾膚鏇膚簾壓網 ~ 窪憲淵網鑰觸壓膚廠夢) 更多 |
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