Clinical Research Directory

LE + CC vs. LE for Ovulation Induction

This randomized controlled trial (RCT) aims to evaluate whether, in infertile women with WHO II/IV ovulatory disorders, a combination of letrozole (LE) and clomiphene citrate (CC) compared to LE alone, result in higher live birth rates. The study is designed as an open-label, multicenter RCT across six fertility clinics in Vietnam. Participants will be randomized into two groups: (1) LE + CC , (2) LE alone. The primary outcome measure is the live birth rate after one treatment cycle. Based on prior data, the live birth rate for IUI in letrozole cycles is estimated at 12%. To detect a 10% increase in live birth rates with CC, 436 couples are needed (α = 0.05, power = 80%). Additionally, the live birth rate after IUI with LE-induced ovulation is approximately 18.7% (Diamond et al., 2015). To detect a 10% increase with CC, 560 couples are required (α = 0.05, power = 80%). Considering a 5% loss to follow-up and protocol deviations, the study plans to recruit 600 participants (150 per arm).

Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)

Women undergoing IVF/ICSI who are candidates for a GnRH-antagonist protocol are randomly assigned 1:1 to oral linzagolix or the standard injectable GnRH antagonist (ganirelix or cetrorelix). A third, non-randomized group of women with a clinical indication for progestin-primed ovarian stimulation (PPOS) - for example, a need for a freeze-all strategy - is enrolled concurrently as a comparator cohort. The randomized comparison (linzagolix vs. injectable antagonist) is the primary, non-inferiority analysis; the PPOS cohort provides an exploratory, non-randomized comparison, analyzed with adjustment for baseline differences.

Follitropin Delta Versus Follitropin Alfa in Indonesian Women Undergoing IUI

The goal of this retrospective observational study is to compare two types of follicle-stimulating hormone, follitropin delta and follitropin alfa, used for ovarian stimulation in Indonesian women undergoing intrauterine insemination (IUI) for infertility treatment. The study includes women younger than 40 years who underwent IUI at Halim Fertility Center, Indonesia, between January 2020 and December 2022. The main questions this study aims to answer are: * Is ovarian stimulation with a simplified follitropin delta dosing regimen associated with a different clinical pregnancy rate compared with conventional follitropin alfa treatment? * Are the rates of multiple pregnancy and ovarian hyperstimulation syndrome (OHSS) different between the two treatment groups? Researchers will compare women who received follitropin delta with women who received follitropin alfa as part of their fertility treatment. The study hypothesis is that a simplified follitropin delta regimen may provide comparable fertility outcomes while maintaining an acceptable safety profile compared with conventional follitropin alfa treatment. Participants had already received one of the two ovarian stimulation treatments as part of their routine clinical care. Researchers will review their medical records and compare treatment characteristics and IUI outcomes between the two groups. The study does not assign participants to treatment because the treatments were given before the study data were analyzed.