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Follitropin Delta Versus Follitropin Alfa in Indonesian Women Undergoing IUI

NCT07801781 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 228

Last updated 2026-09-03

No results posted yet for this study

Summary

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.

Conditions

  • Infertility
  • Ovulation Induction
  • Insemination, Artificial

Interventions

DRUG

Follitropin Delta, Recombinant

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.

DRUG

Follitropin Alfa (GONAL-F)

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.

Sponsors & Collaborators

  • Halim Fertility Center

    collaborator INDUSTRY

  • Stella Maris Women and Children Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07801781 on ClinicalTrials.gov