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

NCT06452511 | Completed Early Phase 1

• 1 other identifier: Azhar524
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS

Keywords

PCOS; Metformin; Pep2dia; overweight

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate:

  detected by positive pregnancy test in serum (Chemical pregnancy) or presence of intrauterine gestational sac (Clinical pregnancy)

  6 months

Secondary Outcomes (4)

• Ovulation rate:

  6 months

• Menstrual cycle regulation

  6 months

• Side effects of both agents

  Throughout the study time (up to 1 year).

• Ongoing pregnancy rate after the first trimester

  first 13 weeks in pregnancy.

Study Arms (2)

Metformin

ACTIVE COMPARATOR

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.

Drug: Metformin

Pep2Dia

ACTIVE COMPARATOR

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.

Drug: pep2dia

Interventions

Metformin DRUG

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.

Metformin

pep2dia DRUG

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.

Pep2Dia

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: This study will include only female participants. The eligibility criteria specify that all participants must be women diagnosed with polycystic ovary syndrome (PCOS) who are experiencing infertility. These women should be overweight, as defined by a body mass index (BMI) within the specified range for the study. No male participants will be included in this trial.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Anovulatory infertile women with PCOS for more than one year associated with overweight and seeking pregnancy.
• Married women of reproductive age who lived with a husband and were sexually active.
• Women with resistant to Letrozole.
• Normal value of prolactin hormone.
• Age group; 18-35 years
• BMI ranging from 25 to 29 kg /m².
• Standard parameters of the husband's semen
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy: lead

Study Sites (1)

Al-Hussein University Hospital

Cairo, 11633, Egypt

Location

MeSH Terms

Conditions

Overweight

Interventions

Metformin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer and consultant at Obstetrics and Gynecology Department.

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 11, 2024
• Study Start: August 1, 2024
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)