Fertility drug combo may boost baby chances for women with irregular periods

NCT ID NCT06934785

Disease control Sponsor: Mỹ Đức Hospital Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study tests whether taking two fertility drugs together (letrozole and clomiphene citrate) works better than letrozole alone for women with ovulation disorders who are trying to conceive. Researchers will compare live birth rates after one treatment cycle in 600 women across six clinics in Vietnam. The goal is to see if the combination leads to more successful pregnancies.

What this could mean

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

Active substance: letrozole and clomiphene citrate
What this could lead to: If successful, this combination could offer a more effective fertility treatment for women with ovulation problems, increasing their chances of having a baby.
What could go wrong: This is a mid-stage trial, and the expected improvement is modest (10% increase in live births). Results may not apply to all populations, and side effects from the drugs are possible.

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Study facts

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

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

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.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Women 18-40 years of age * Having ovulation disorder (length of cycle \< 21 or \> 35 days or having \< 8 cycles per year) * FSH ≥5 IU/L and ≤25 IU/L, or LH ≥5 IU/L and AMH ≥1.2 ng/mL * Progressive motility (PR) ≥ 32% OR total progressive motility sperm count \> 5 million; and sperm concentration ≥ 5 million/ml, (World Health Organization, 2021) * Agreeing to take part in study. * Not participating in other studies. Exclusion Criteria: * Untreated thyroid disease; Thyroid disease is suspected if patients have one of these (Bednarczuk et al., 2021); TSH ≥4 mIU/L or TSH ≥2.5mIU/L and TPOAb (+) or TSH \<0.1mIU/L * Untreated hyper-prolactinemia; Hyperprolactinemia is suspected if patients have prolactinemia concentration \>50 ng/mL (The sample is collected after an overnight fast, at least 2 hours after waking up, ensuring that venipuncture does not cause excessive stress.) * Allergy or having contraindications to LE or CC; * Unilateral or Bilateral fallopian tube blockage (HSG, HyFoSy or surgery confirmation) * Untreated endometrial abnormalities include endometrial hyperplasia, intrauterine adhesions, endometrial polyp, or chronic endometritis. * Uterine abnormalities include leiomyomas L0, L1, or L2; severe adenomyosis; congenital uterine abnormalities, include didelphus, arcuate, unicornuate, bicornuate, septate.

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Conditions

The condition(s) this trial relates to.

anovulation

As listed by the trial registrant

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

Clomiphene citrate Letrozole Ovulation disorder Ovulation induction

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Fertility drug combo may boost baby chances for women with irregular periods

What the study statuses mean