An observational study in Infertility, Ovulation Induction and Insemination, Artificial, sponsored by Stella Maris Women and Children Hospital. Completed at 1 site in Indonesia. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Stella Maris Women and Children Hospital · Observational
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:
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 228 is above the median of 200 across 592 observational studies indexed under Infertility.
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The study population consisted of women younger than 40 years who underwent controlled ovarian stimulation followed by intrauterine insemination (IUI) at Halim Fertility Center, Indonesia, between January 2020 and December 2022. Participants had infertility associated with unexplained infertility, anovulation, mild male-factor infertility, or combined infertility factors and met the predefined eligibility criteria. Women were classified according to the ovarian stimulation received: follitropin alfa or follitropin delta.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Women undergoing IUI who received controlled ovarian stimulation with follitropin delta, starting at 5 μg/day, with dose adjustment according to ovarian response. This cohort serves as the study group.
Drug: Follitropin Delta, Recombinant
Women undergoing IUI who received controlled ovarian stimulation with follitropin alfa, starting at 75 IU/day, with dose adjustment according to ovarian response. This cohort serves as the control group.
Drug: Follitropin Alfa (GONAL-F)
Follitropin delta was administered once daily beginning on cycle day 2 or 3 at an initial dose of 5 μg/day using a simplified dose-equivalent regimen. The dose could be adjusted according to ovarian response assessed by ultrasound monitoring. Stimulation was continued until the leading follicle reached ≥17 mm in diameter, followed by final oocyte maturation triggering and intrauterine insemination approximately 36 hours later.
Follitropin alfa was administered once daily beginning on cycle day 2 or 3 at an initial dose of 75 IU/day. The dose could be adjusted according to ovarian response assessed by ultrasound monitoring. Stimulation was continued until the leading follicle reached ≥17 mm in diameter, followed by final oocyte maturation triggering and intrauterine insemination approximately 36 hours later.
Clinical Pregnancy Rate
The proportion of IUI cycles resulting in a clinical pregnancy. Clinical pregnancy was defined as ultrasonographic visualization of one or more gestational sacs or other definitive clinical evidence of pregnancy.
Time frame: During early pregnancy follow-up 4-6 weeks after IUI
Multiple Pregnancy Rate
The proportion of IUI cycles resulting in a multiple clinical pregnancy, defined as the presence of more than one gestational sac identified by ultrasonography.
Time frame: During early pregnancy follow-up 4-6 weeks after IUI
Ovarian Hyperstimulation Syndrome Rate
The proportion of IUI cycles in which ovarian hyperstimulation syndrome (OHSS) occurred following controlled ovarian stimulation.
Time frame: 2-4 weeks after IUI
Ran from Jan 2020 to primary completion in Dec 2022, 35 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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