InfertilityNCT07801781
Follitropin Delta Versus Follitropin Alfa in Indonesian Women Undergoing IUI
An observational study of Infertility and Ovulation Induction, run by Stella Maris Women and Children Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Ovulation Induction, Insemination, Artificial
- What is being tested?
- Follitropin Delta, Recombinant and Follitropin Alfa (GONAL-F)
- How many people
- 228 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- Pre-existing medical conditions considered unsuitable for IUI treatment
- Endometriotic cyst
- Adenomyosis
- Congenital uterine anomalies
- Spontaneous ovulation
- Poor ovarian response
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Clinical Outcome Between Follitropin Delta With Simplified Dosage Equivalent and Follitropin Alfa in Indonesian Women Undergoing Intrauterine Insemination
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:
Read more
- 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
- Being tested
- Follitropin Delta, Recombinant, Follitropin Alfa (GONAL-F)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin Delta, RecombinantDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Follitropin Alfa (GONAL-F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During early pregnancy follow-up 4-6 weeks after IUI
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2-4 weeks after IUI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stella Maris Women and Children Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Halim Fertility Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801781
- Sponsor's protocol ID
- 011-1/Dir/RSIA.SM/I/2023
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Outcome Between Follitropin Delta With Simplified Dosage Equivalent and Follitropin Alfa in Indonesian Women Undergoing Intrauterine Insemination
- ClinicalTrials.gov ID
- NCT07801781
- Acronym / sponsor ID
- 011-1/Dir/RSIA.SM/I/2023
- Conditions
- Infertility, Ovulation Induction, Insemination, Artificial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Stella Maris Women and Children HospitalUniversity, hospital or other
- Collaborators
- Halim Fertility Center
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follitropin Delta | – | Drug: Follitropin Delta, RecombinantWomen 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. |
| Follitropin Alfa | – | Drug: Follitropin Alfa (GONAL-F)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- Pre-existing medical conditions considered unsuitable for IUI treatment
- Endometriotic cyst
- Adenomyosis
- Congenital uterine anomalies
- Spontaneous ovulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follitropin Delta, RecombinantFollitropin 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 Delta |
| 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. | Drug | Follitropin Alfa |
Primary outcome
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.
2 secondary outcomes
Multiple Pregnancy Rate
Time frame: During early pregnancy follow-up 4-6 weeks after IUI
Ovarian Hyperstimulation Syndrome Rate
Time frame: 2-4 weeks after IUI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Ovulation Induction, run by Stella Maris Women and Children Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (time frame: During early pregnancy follow-up 4-6 weeks after IUI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.