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联合小剂量人绒毛膜促性腺激素(hCG)和枸橼酸氯米酚(CC)与持续 CC 治疗 CC 抵抗型多囊卵巢综合征患者排卵诱导的疗效比较:一项随机对照试验。

Competence of Combined Low Dose of Human Chorionic Gonadotropin (HCG) and Clomiphene Citrate (CC) Versus Continued CC during Ovulation Induction in Women with CC-Resistant Polycystic Ovarian Syndrome: A Randomized Controlled Trial.

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Mansoura University, Mansoura 35111, Egypt.

Department of Obstetrics and Gynecology, College of Medicine, Jouf University, Sakaka 72388, Saudi Arabia.

出版信息

Medicina (Kaunas). 2024 Aug 12;60(8):1300. doi: 10.3390/medicina60081300.

Abstract

: Polycystic ovarian syndrome (PCOS) is a widespread endocrine disorder affecting 5-18% of females in their childbearing age. The aim of this study is to assess the efficacy of combining a low dosage of human chorionic gonadotropin (HCG) along with clomiphene citrate (CC) for stimulating ovulation in infertile women diagnosed with CC-resistant PCOS. : A randomized controlled trial was carried out on 300 infertile CC-resistant PCOS women. All participants were assigned to two groups: the CC-HCG group and the CC-Placebo group. Subjects in the CC-HCG group were given CC (150 mg/day for 5 days starting on the 2nd day of the cycle) and HCG (200 IU/day SC starting on the 7th day of the cycle). Subjects in the CC-Placebo group were given CC and a placebo. The number of ovarian follicles > 18 mm, cycle cancellation rate, endometrial thickness, ovulation rate, clinical pregnancy rate, and occurrence of early ovarian hyper-stimulation syndrome were all outcome variables in the primary research. : Data from 138 individuals in the CC-HCG group and 131 participants in the CC-Placebo group were subjected to final analysis. In comparison to the CC-Placebo group, the cycle cancellation rate in the CC-HCG group was considerably lower. The CC-HCG group exhibited a substantial increase in ovarian follicles reaching > 18 mm, endometrial thickness, and ovulation rate. The clinical pregnancy rate was higher in the CC-HCG group (7.2% vs. 2.3%; CC-HCG vs. CC-Placebo). Upon adjusting for BMI and age, the findings of our study revealed that individuals in the CC-HCG group who had serum prolactin levels below 20 (ng/mL), secondary infertility, infertility duration less than 4 years, baseline LH/FSH ratios below 1.5, and serum AMH levels more than 4 (ng/mL) had a higher likelihood of achieving pregnancy. In the CC-Placebo group, there was a greater prediction of clinical pregnancy for those with serum AMH (<4), primary infertility, serum prolactin ≤ 20 (ng/mL), baseline LH/FSH < 1.5, and infertility duration < 4 years. : The use of a small dose of HCG along with CC appeared to be an effective treatment in reducing cycle cancelation, improving the clinical pregnancy rate and ovulation rate in CC-resistant PCOS patients. The trial was registered with Clinical Trials.gov, identifier NCT02436226.

摘要

多囊卵巢综合征(PCOS)是一种常见的内分泌紊乱疾病,影响着 5-18%的育龄期女性。本研究旨在评估低剂量人绒毛膜促性腺激素(HCG)联合枸橼酸氯米酚(CC)治疗对氯米酚耐药的多囊卵巢综合征不孕患者排卵的疗效。

这是一项针对 300 例氯米酚耐药的多囊卵巢综合征不孕患者的随机对照试验。所有参与者被分为两组:CC-HCG 组和 CC-安慰剂组。CC-HCG 组患者给予 CC(150mg/d,第 2 天开始,连用 5 天)和 HCG(200IU/d,皮下注射,第 7 天开始)。CC-安慰剂组患者给予 CC 和安慰剂。主要研究的结局变量包括:>18mm 的卵巢卵泡数、周期取消率、子宫内膜厚度、排卵率、临床妊娠率和早发性卵巢过度刺激综合征的发生。

最终对 CC-HCG 组的 138 名患者和 CC-安慰剂组的 131 名患者进行了数据分析。与 CC-安慰剂组相比,CC-HCG 组的周期取消率显著降低。CC-HCG 组>18mm 的卵巢卵泡数、子宫内膜厚度和排卵率显著增加。CC-HCG 组的临床妊娠率较高(7.2% vs. 2.3%;CC-HCG 组 vs. CC-安慰剂组)。在调整 BMI 和年龄后,本研究发现血清催乳素水平<20ng/ml、继发不孕、不孕时间<4 年、基础 LH/FSH 比值<1.5、血清 AMH 水平>4ng/ml 的 CC-HCG 组患者妊娠率较高。在 CC-安慰剂组中,血清 AMH<4ng/ml、原发不孕、血清催乳素≤20ng/ml、基础 LH/FSH<1.5 和不孕时间<4 年的患者更有可能出现临床妊娠。

综上所述,在氯米酚耐药的多囊卵巢综合征患者中,使用小剂量 HCG 联合 CC 可减少周期取消,提高临床妊娠率和排卵率。该试验已在 ClinicalTrials.gov 注册,编号为 NCT02436226。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48c0/11356540/adb0031bb80d/medicina-60-01300-g001.jpg

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