Follitropin Delta Versus Follitropin Alfa in Indonesian Women Undergoing IUI

NCT07801781 | Completed

• 1 other identifier: 011-1/Dir/RSIA.SM/I/2023
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  During early pregnancy follow-up 4-6 weeks after IUI

Secondary Outcomes (2)

• Multiple Pregnancy Rate

  During early pregnancy follow-up 4-6 weeks after IUI

• Ovarian Hyperstimulation Syndrome Rate

  2-4 weeks after IUI

Study Arms (2)

Follitropin Delta

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

Follitropin Alfa

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)

Interventions

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 Delta

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.

Follitropin Alfa

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stella Maris Women and Children Hospital: lead
• Halim Fertility Center: collaborator

Study Sites (1)

RSIA Stella Maris

Medan, North Sumatera, 20152, Indonesia

Location

MeSH Terms

Conditions

Infertility

Interventions

follitropin delta; follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 3, 2026

Record last verified: 2026-08

Locations

ID (1)