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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

March 25, 2025

Study Completion Date

March 25, 2025

Conditions
PCOS
Interventions
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.

Trial Locations (1)

11633

Al-Hussein University Hospital, Cairo

All Listed Sponsors
lead

Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy

OTHER

NCT06452511 - Comparing the Effect of Metformin vs. Pep2dia as an Adjunct to Letrozole on Ovulation Induction and Pregnancy Outcomes in Overweight Women With PCOS | Biotech Hunter | Biotech Hunter