NCT06452511

Comparing the Effect of Metformin vs. Pep2dia as an Adjunct to Letrozole on Ovulation Induction and Pregnancy Outcomes in Overweight Women With PCOS

Comparing the Effect of Metformin vs. Pep2dia as an Adjunct to Letrozole on Ovulation Induction and Pregnancy Outcomes in Overweight Women With PCOS; A Randomized Controlled Open-Label Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the effects of Metformin versus Pep2dia as adjunct treatments to Letrozole on ovulation induction and pregnancy outcomes in overweight women with polycystic ovary syndrome (PCOS). The main questions it aims to answer are: Does Metformin improve ovulation rates more effectively than Pep2dia when used alongside Letrozole? Does Pep2dia enhance pregnancy outcomes compared to Metformin in this patient population? Participants will: Receive either Metformin or Pep2dia in addition to Letrozole. Undergo regular monitoring for ovulation and pregnancy outcomes. Researchers will compare the Metformin group to the Pep2dia group to see if there is a significant difference in ovulation and pregnancy rates between the two treatments.

Conditions

• PCOS

Interventions

Type	Name	Description
DRUG	Metformin	In the Metformin arm of this study, 50 overweight women with polycystic ovary syndrome (PCOS) and infertility will receive a combination treatment of Letrozole and Metformin. Letrozole, aimed at inducing ovulation, will be administered according to a specified dosage regimen, alongside Metformin, an insulin-sensitizing agent used to manage PCOS, prescribed at a specified dosage regimen. Participants will undergo regular monitoring to assess ovulation and pregnancy outcomes, involving baseline assessments of health status and fertility parameters, ongoing monitoring visits to track ovulation through ultrasound and hormone levels, and final evaluation of ovulation rates and pregnancy outcomes at the study's end. This arm seeks to determine the efficacy of Metformin as an adjunct to Letrozole in improving ovulation induction and pregnancy rates among overweight women with PCOS.
DRUG	pep2dia	In the Pep2dia arm of this study, 50 overweight women diagnosed with polycystic ovary syndrome (PCOS) and experiencing infertility will receive a combination treatment of Letrozole and Pep2dia. Letrozole, utilized to induce ovulation, will be administered according to a specified dosage regimen, along with Pep2dia, a peptide-based therapy tailored to manage PCOS, prescribed at a specified dosage regimen. Participants will undergo regular monitoring to assess ovulation and pregnancy outcomes, involving baseline assessments of health status and fertility parameters, ongoing monitoring visits to track ovulation through ultrasound and hormone levels, and a final evaluation of ovulation rates and pregnancy outcomes at the conclusion of the study period. This arm seeks to ascertain the effectiveness of Pep2dia as an adjunct to Letrozole in enhancing ovulation induction and pregnancy rates among overweight women with PCOS.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-03-25
• Completion: 2025-03-25
• First posted: 2024-06-11
• Last updated: 2025-03-28

Locations

1 site across 1 country: Egypt