枸橼酸西地那非与戊酸雌二醇作为不明原因不孕症患者枸橼酸氯米芬辅助卵巢刺激周期佐剂的比较疗效：一项双盲随机对照试验。

Comparative effectiveness of sildenafil citrate and estradiol valerate as adjuvants during clomiphene citrate-assisted ovarian stimulation cycles in patients with unexplained infertility: a double-blind randomized controlled trial.

作者信息

Bosenge-Nguma Jean-Didier, O'yandjo Antoine Modia, Djang'eing'a Roland Marini, Skv Juakali, Otuli Noël Labama, Ntokamunda Justin Kadima, Chin Alexis Heng Boon, Bosunga Gédéon Katenga

机构信息

Department of Obstetrics and Gynaecology, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo.

Department of Pharmaceutical Sciences, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo.

出版信息

Contracept Reprod Med. 2024 Oct 9;9(1):48. doi: 10.1186/s40834-024-00307-6.

DOI:10.1186/s40834-024-00307-6

PMID:39385289

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11462857/

Abstract

OBJECTIVE

This study aimed to assess the effect of sildenafil citrate and estradiol valerate as adjuvant therapy during ovarian stimulation cycles with clomiphene citrate in patients with unexplained infertility in Kisangani.

METHOD

A double-blind, randomized controlled trial was conducted for two years at two specialized health facilities in Kisangani (University Clinics of Kisangani and "Clinique des Anges Kisangani"). The population included 148 patients, 74 of whom were on clomiphene citrate + sildenafil citrate (CCSC) regimens and 74 of whom were on clomiphene citrate + estradiol valerate (CCEV) regimens for three months. The primary indicator was the conception rate, with secondary outcomes encompassing endometrial thickness, appearance and vascularity, the number of mature follicles and ovulation rate.

RESULTS

The two groups were comparable in terms of sociodemographic and clinical characteristics. The mean duration of attempting to conceive was 4.39 years versus 4.36 years (P = 0.839), while the mean AFC was 11.51 versus 11.46 (P = 0.831), in the CCSC group versus CCEV group respectively. Secondary infertility was the most frequent diagnosis in each of the two groups. The biochemical pregnancy rate was comparable between the two groups (P = 0.385), while the clinical pregnancy rate was significantly higher in the CCSC group versus CCEV group (P = 0.04). Both perifollicular flow and the ovulation rate were significantly higher in the CCSC group versus the CCEV group (P = 0.006 and P = 0.002 respectively). However, endometrial vascularity/thickness, and the number of Graafian follicles were not significantly different between the two groups.

CONCLUSION

As an adjuvant, sildenafil increases the rate of clinical pregnancy more than does estradiol in patients with unexplained infertility undergoing ovarian stimulation with clomiphene citrate.

STUDY REGISTRATION

PACTR 202,310,849,449,401 (Pan African Clinical Trials Registry).

摘要

目的

本研究旨在评估枸橼酸西地那非和戊酸雌二醇作为辅助治疗在基桑加尼不明原因不孕症患者枸橼酸氯米芬卵巢刺激周期中的效果。

方法

在基桑加尼的两个专业医疗机构（基桑加尼大学诊所和“基桑加尼天使诊所”）进行了一项为期两年的双盲随机对照试验。研究对象包括148名患者，其中74名采用枸橼酸氯米芬+枸橼酸西地那非（CCSC）方案，74名采用枸橼酸氯米芬+戊酸雌二醇（CCEV）方案，为期三个月。主要指标是受孕率，次要结果包括子宫内膜厚度、外观和血管情况、成熟卵泡数量和排卵率。

结果

两组在社会人口统计学和临床特征方面具有可比性。CCSC组与CCEV组相比，平均受孕尝试时间分别为4.39年和4.36年（P = 0.839），平均窦卵泡计数分别为11.51和11.46（P = 0.831）。继发性不孕是两组中最常见的诊断。两组的生化妊娠率相当（P = 0.385），而CCSC组的临床妊娠率显著高于CCEV组（P = 0.04）。CCSC组的卵泡周血流和排卵率均显著高于CCEV组（分别为P = 0.006和P = 0.002）。然而，两组之间的子宫内膜血管情况/厚度以及格拉夫卵泡数量没有显著差异。