Hakimi Parvin, Alborzi Mahshid, Nikkhou Ehsan, Azizi Hosein
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Department of Infertility Center, Jahrom University of Medical Sciences, Jahrom, Iran.
Eur J Med Res. 2024 Dec 31;29(1):639. doi: 10.1186/s40001-024-02242-3.
There are limited and controversial findings concerning ovulation induction using intrauterine and intramuscular human chorionic gonadotropin (hCG) injection compared to intramuscular hCG alone. The study aimed to examine the impact of intrauterine hCG injection, which is used to induce ovulation, on the efficacy of the intrauterine insemination (IUI) technique in patients with unexplained infertility.
A randomized controlled clinical trial was conducted involving 80 subjects with unexplained primary infertility at the infertility clinic of Al-Zahra Hospital in northwest Iran. Patients were randomly allocated into two groups: control and intervention. Both groups received initial treatment with letrozole and Recombinant follicle-stimulating hormone (r-FSH). After confirmation of at least one follicle measuring 18 mm or larger through ultrasonography, in the control group, two ampoules of 5000 units of hCG were administered intramuscularly. The intervention group received 500 units of hCG diluted in 0.5 cc of normal saline and was injected into the uterine cavity along with the two intramuscular ampoules. Primary outcomes were clinical and chemical pregnancy rates and the secondary outcome was any adverse pregnancy outcomes. Multiple logistic regression analysis was used to estimate crude and adjusted odds ratios (AORs) of the pregnancy rates with 95% confidence intervals (CIs).
No significant differences were found between the two groups regarding baseline characteristics (p > 0.05). Chemical and clinical pregnancy rates in the control and intervention groups were (32.5 vs. 40%) (32.5% vs. 35%), respectively. In the final analysis after adjusting the potential confounders, intrauterine and intramuscular hCG injection increased the likelihood of chemical pregnancy by 1.39 times AOR = 1.42 (1.31-4.12; p = 0.036), and clinical pregnancy by AOR = 1.25 (1.03-3.74; p = 0.048) compared to intramuscular hCG alone. There were no statistical differences regarding adverse pregnancy outcomes between the study groups (p value > 0.05).
It seems that ovulation induction through intrauterine and intramuscular hCG injection increased the odds of both chemical and clinical pregnancy rates compared with intramuscular hCG alone. Multicenter clinical trials and meta-analysis studies are needed for decision making in clinical settings.
与单纯肌内注射人绒毛膜促性腺激素（hCG）相比，关于宫腔内和肌内注射hCG诱导排卵的研究结果有限且存在争议。本研究旨在探讨用于诱导排卵的宫腔内注射hCG对不明原因不孕症患者宫腔内人工授精（IUI）技术疗效的影响。
在伊朗西北部的阿尔扎赫拉医院不孕症门诊进行了一项随机对照临床试验，纳入80例不明原因原发性不孕症患者。患者被随机分为两组：对照组和干预组。两组均接受来曲唑和重组促卵泡激素（r-FSH）的初始治疗。经超声检查确认至少有一个卵泡直径达到18mm或更大后，对照组肌内注射两支5000单位的hCG。干预组将500单位hCG用0.5cc生理盐水稀释后，与两支肌内注射的hCG一起注入宫腔。主要结局为临床妊娠率和生化妊娠率，次要结局为任何不良妊娠结局。采用多元逻辑回归分析来估计妊娠率的粗比值比和调整后的比值比（AOR）以及95%置信区间（CI）。
两组在基线特征方面无显著差异（p＞0.05）。对照组和干预组的生化妊娠率和临床妊娠率分别为（32.5%对40%）（32.5%对35%）。在对潜在混杂因素进行调整后的最终分析中，与单纯肌内注射hCG相比，宫腔内和肌内注射hCG使生化妊娠的可能性增加了1.39倍，AOR = 1.42（1.31 - 4.12；p = 0.036），临床妊娠的AOR = 1.25（1.03 - 3.74；p = 0.048）。研究组之间在不良妊娠结局方面无统计学差异（p值＞0.05）。
与单纯肌内注射hCG相比，宫腔内和肌内注射hCG诱导排卵似乎增加了生化妊娠率和临床妊娠率的几率。在临床环境中进行决策需要多中心临床试验和荟萃分析研究。
