Effect of ALA Combined with Letrozole on Polycystic Ovary Syndrome Clinical Outcome in Infertile Females

Launched by AIN SHAMS UNIVERSITY · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of adding a supplement called Alpha lipoic acid (ALA) to a medication called letrozole for women with polycystic ovary syndrome (PCOS) who are struggling to become pregnant. The goal is to see if ALA can improve fertility outcomes when taken alongside letrozole, which is already a standard treatment for PCOS-related infertility. The study will involve 150 women aged 18 to 35 who have been diagnosed with PCOS and have been trying to conceive for at least a year. Eligible participants must have at least one healthy fallopian tube and a male partner with a normal sperm count.

During the trial, women will be randomly assigned to either receive letrozole alone or letrozole plus ALA. Both groups will also receive lifestyle counseling. Participants will be monitored through ultrasounds to track their ovulation and the health of their reproductive organs. If a follicle (part of the ovary where eggs develop) reaches the right size, participants will receive an injection to help with ovulation and will be advised to try to conceive shortly after. The study will last for up to three treatment cycles or until pregnancy occurs, and researchers will collect data on various health measurements to see if ALA provides any extra benefits. If you are considering participating, this trial offers a chance to explore a potentially effective treatment option for infertility related to PCOS.

Gender

FEMALE

Eligibility 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.