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Antioxidant supplement tested as fertility booster for PCOS

NCT ID NCT06418347

Symptom relief Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing whether adding alpha-lipoic acid, an antioxidant supplement, to standard letrozole treatment helps infertile women with polycystic ovary syndrome ovulate and become pregnant. The trial enrolls 150 women aged 18 to 35 who are trying to conceive. Both groups receive letrozole and lifestyle counseling, while one group also takes alpha-lipoic acid three times daily. The study tracks ovulation, pregnancy, hormone levels, and metabolic markers over up to three treatment cycles.

What this could mean

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

Active substance
alpha-lipoic acid, an antioxidant supplement
What this could lead to
If it works, adding a cheap antioxidant supplement could give women with PCOS a better shot at ovulating and conceiving during letrozole treatment.
What could go wrong
This is a single-center study of 150 women, and supplement effects are often modest. Alpha-lipoic acid can cause stomach upset, and it may not add enough benefit to justify routine use.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

150 people

The number who actually took part.

Started

Apr 2024

Finished

Aug 2025

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 35 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: * Female patient aged 18-35 * Willing to conceive * PCOS, diagnosed according to the revised 2003 Rotterdam consensus criteria. " Oligo- or anovulation secondary to PCOS and at least one of the remaining two criteria: hyperandrogenism or polycystic ovarian morphology on ultrasound . * Anovulation and/or infertility ≥ 1 year. * At least one patent fallopian tube * Normal uterine cavity * Male partner with sperm concentration of at least 14 million/mL in at least one ejaculate. Exclusion Criteria: * Other causes for the infertility (male factor, tubal factor). * Intake of hormonal or other drugs that can potentially influence the ovulation. * Causes of anovulation or hyperandrogenism other than PCOS such as uncontrolled thyroid dysfunction or hyperprolactinemia. * Contraindication to pregnancy * Myo-inositol use \< 3 months prior to study enrollment * Concomitant metformin use. Previous use is allowed with last use at least 6 weeks prior to randomization.

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Conditions

The condition(s) this trial relates to.

female infertility infertility disorder polycystic ovary syndrome

As listed by the trial registrant

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

Infertility, female Polycystic ovary syndrome

Contacts and locations

Locations

  • Ain shams university

    Cairo, Cairo Governorate, 11566, Egypt

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