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Completed

NCT Number: NCT07801781

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.

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Key information

Conditions

Infertility Genital Diseases Insemination, Artificial Ovulation Induction Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

RSIA Stella Maris

Medan, North Sumatera, 20152, Indonesia

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female age <40 years
  • Undergoing intrauterine insemination (IUI) for infertility treatment
  • Bilateral tubal patency
  • Unexplained infertility, anovulation, and/or mild male-factor infertility
  • For mild male-factor infertility: total motile sperm count (TMSC) 10-20×10^6/mL
  • Baseline serum FSH <10 mIU/mL

Exclusion criteria

  • Pre-existing medical conditions considered unsuitable for IUI treatment
  • Endometriotic cyst
  • Adenomyosis
  • Congenital uterine anomalies
  • Spontaneous ovulation
  • Poor ovarian response

Treatment and study plan

Follitropin Delta, Recombinant

Drug

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 (GONAL-F)

Drug

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.

Primary outcomes

  1. Clinical Pregnancy Rate

    Time frame: During early pregnancy follow-up 4-6 weeks after IUI

    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.

Secondary outcomes

  1. Multiple Pregnancy Rate

    Time frame: During early pregnancy follow-up 4-6 weeks after IUI

    The proportion of IUI cycles resulting in a multiple clinical pregnancy, defined as the presence of more than one gestational sac identified by ultrasonography.

  2. Ovarian Hyperstimulation Syndrome Rate

    Time frame: 2-4 weeks after IUI

    The proportion of IUI cycles in which ovarian hyperstimulation syndrome (OHSS) occurred following controlled ovarian stimulation.

Sponsors and collaborators

Lead sponsor

Stella Maris Women and Children Hospital

Other

Collaborators

  • Halim Fertility Center

Registry information

Official study title

Comparative Clinical Outcome Between Follitropin Delta With Simplified Dosage Equivalent and Follitropin Alfa in Indonesian Women Undergoing Intrauterine Insemination

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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