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Can a simpler fertility drug dose match the standard for IUI success?

NCT ID NCT07801781

Disease control Sponsor: Stella Maris Women and Children Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study compares two follicle-stimulating hormones, follitropin delta and follitropin alfa, used to stimulate the ovaries in Indonesian women under 40 undergoing intrauterine insemination (IUI) for infertility. Researchers will review medical records from a fertility center to see whether a simplified follitropin delta dosing regimen leads to similar clinical pregnancy rates as the conventional follitropin alfa treatment. They will also check for differences in multiple pregnancy and ovarian hyperstimulation syndrome rates. The study does not assign treatments; it looks back at cycles already completed as part of routine care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Follitropin delta (a follicle-stimulating hormone) compared with follitropin alfa (GONAL-F)
What this could lead to
If follitropin delta with a simplified dosing works as well as follitropin alfa, it could offer a more convenient and equally effective option for ovarian stimulation in IUI.
What could go wrong
This is a retrospective review of past records, not a controlled experiment, so differences between groups may reflect patient factors rather than the drugs. Results may not apply beyond this Indonesian clinic.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

228 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 40 years

Sex

Female participants only

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

infertility disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infertility Insemination, artificial Ovulation induction

Contacts and locations

Locations

  • RSIA Stella Maris

    Medan, North Sumatera, 20152, Indonesia

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