Comparison of Low-dose Human Menopausal Gonadotropins with Clomiphene Citrate for Ovarian Stimulation in Intrauterine Insemination: A Randomized Clinical Trial

Abstract

Introduction: Intrauterine insemination (IUI) is the treatment of choice for unexplained and mild male factor infertile couples not responding to ovulation induction (OI). Clomiphene citrate (CC) is the most common OI used but the success of pregnancy is very low due to its antiestrogenic effects. Gonadotropins are the second line of treatment in CC-resistant cases but they had the disadvantage of being costly with the risk of multiple pregnancies and ovarian hyperstimulation. However, low-dose human menopausal gonadotropins (hMG) have been found to be effective in these conditions with less risk of side effects. Objectives: To assess the efficacy of ovarian stimulation of low-dose hMG and CC with IUI on pregnancy rate in unexplained infertility. Materials and methods: The study was randomized control clinical trial conducted at a tertiary care hospital in South India. A total of 224 patients were randomized to two groups: the low-dose hMG group (75 IU) and CC group (100 mg). Women aged between 25 and 30 years with either unexplained or mild male factor infertility were included. All women were monitored for a follicular response, endometrial thickness, and ovulation. IUI procedure was done after 36–42 hours after HCG trigger. Statistical analysis was done using SPSS version 22 with Chi-square test and student t-test as statistical tests. Results: The demography characteristics like age, duration of infertility, cause of infertility were almost similar in both groups. Compared to ovarian stimulation with CC, hMG stimulation was associated with more number of dominant follicles (2.2 ± 0.5 vs 1.9 ± 0.4) (p = 0.001), increased endometrial thickness (10 ± 1.3 mm vs 7.8 ± 0.15 mm and better pregnancy rate (31.2% vs 16.9%). Conclusion: Low-dose human menopausal gonadotropins have a better pregnancy rate (31.2%) in comparison to clomiphene citrate (16.9%) when used for ovulation induction with IUI in patients with unexplained infertility and mild male factor infertility. Low-dose hMG was associated with more dominant follicles and better endometrial thickness which may lead to favorable reproductive outcomes. Clinical significance: Low-dose gonadotropins can be considered for ovarian stimulation in IUI for better pregnancy rate and without any side effects, especially in low-resource settings.