Combining ALA with Letrozole for treating infertility in women with PCOS
Effect of Alpha-Lipoic Acid Supplementation on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females Treated With Letrozole
This study is testing if adding Alpha lipoic acid (ALA) to letrozole can help women with PCOS who are struggling with infertility get pregnant more effectively.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT06418347 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-35 diagnosed with PCOS and experiencing infertility for at least one year.
Not a fit: Patients with infertility due to factors other than PCOS or those with contraindications to pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve fertility rates in women with PCOS.
How similar studies have performed: While the combination of ALA and letrozole is a novel approach, previous studies have shown that letrozole is effective for treating infertility in PCOS.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cairo and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.