Combining ALA with Letrozole for treating infertility in women with PCOS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of adding Alpha lipoic acid (ALA) to letrozole treatment in women with polycystic ovary syndrome (PCOS) who are experiencing infertility. A total of 150 participants will be randomly assigned to either a control group receiving letrozole alone or an intervention group receiving letrozole along with ALA supplements. The study will monitor the participants' ovulation rates and overall clinical outcomes through trans-vaginal ultrasound scans and follow standard PCOS care protocols. The goal is to determine if the addition of ALA enhances fertility outcomes compared to letrozole alone.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ain shams university
  Cairo, Egypt Recruiting
• Ain shams university
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Muoaz A. Sallam, Teaching assistance
• Email: Moaaz.ahmed22@pharma.asu.edu.eg
• Phone: +0201102174081

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.