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

Early Phase 1

Completed

• Conditions: PCOS
• Interventions: Drug: pep2dia; Drug: Metformin

• Registration Number: NCT06452511
• Lead Sponsor: Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-01
• Study First Submitted QC: 2024-06-05
• Study First Posted: 2024-06-11
• Study Start: 2024-08-01
• Status Verified: 2025-03
• Primary Completion: 2025-03-25
• Study Completion: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Anovulatory infertile women with PCOS for more than one year associated with overweight and seeking pregnancy.
2. Married women of reproductive age who lived with a husband and were sexually active.
3. Women with resistant to Letrozole.
4. Normal value of prolactin hormone.
5. Age group; 18-35 years
6. BMI ranging from 25 to 29 kg /m².
7. Standard parameters of the husband's semen
8. Diagnostic criteria for Rotterdam diagnosis of polycystic ovary syndrome:

Two of the following three criteria are required:

• Oligoovulation or Anovulation
• Hyperandrogenism: Clinical (hirsutism or less commonly male pattern alopecia) or Biochemical (raised free androgen index (FAI) or free testosterone).
• Polycystic ovaries on ultrasound (Christ et al., 2023).

Exclusion Criteria

1. Hypersensitivity to letrozole, metformin or pep2dia.
2. Obese women with BMI ≥29 kg/m² or women with BMI <25 kg/m².
3. FSH above 11 mg.
4. Any other cause of infertility other than anovulation due to overweight as uterine factor, tubal factor, male factor, ovarian pathology or endometriosis.
5. Any medical disorder that may affect pregnancy or systemic disease (cardiovascular, renal, hepatic, CNS diseases and hypo or hyperthyroidism)
6. Missed patient
7. Discontinuation of drug due to its side effects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pep2Dia	pep2dia	In the Pep2dia arm of this study, 50 overweight women with polycystic ovary syndrome (PCOS) who are experiencing infertility will participate. These participants will receive Letrozole for ovulation induction in combination with Pep2dia. The study will monitor these women to assess the efficacy of this treatment regimen on inducing ovulation and improving pregnancy outcomes. Participants will be closely observed for any side effects, and their progress will be regularly evaluated to determine the effectiveness of Pep2dia as an adjunct therapy to Letrozole in this specific patient population.
Metformin	Metformin	In the Metformin arm of this study, 50 overweight women with polycystic ovary syndrome (PCOS) who are experiencing infertility will participate. These participants will receive Letrozole for ovulation induction in combination with Metformin. The study will monitor these women to assess the efficacy of this treatment regimen on inducing ovulation and improving pregnancy outcomes. Participants will be closely observed for any side effects and their progress will be regularly evaluated to determine the effectiveness of Metformin as an adjunct therapy to Letrozole in this specific patient population.

Primary Outcome Measures

Name	Time	Method
Pregnancy rate:	6 months	detected by positive pregnancy test in serum (Chemical pregnancy) or presence of intrauterine gestational sac (Clinical pregnancy)

Secondary Outcome Measures

Name	Time	Method
Menstrual cycle regulation	6 months	Detection of regulation of the menstrual cycle that is not regular in patients with PCOS assessed as cycle length 21-35 days.
Ongoing pregnancy rate after the first trimester	first 13 weeks in pregnancy.	Assessment of the proportion of pregnancies that progress beyond the first trimester
Ovulation rate:	6 months	detected by folliculometry and midluteal progesterone in serum (higher than 3 ng/mL)
Side effects of both agents	Throughout the study time (up to 1 year).	Monitoring and recording of any adverse effects experienced by participants during the study period

Trial Locations

Locations (1)

Al-Hussein University Hospital; 🇪🇬 Cairo, Egypt