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Completed

NCT Number: NCT06452511

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

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.

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Key information

Conditions

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

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Al-Hussein University Hospital

Cairo, 11633, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pregnancy rate:

    Time frame: 6 months

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

Secondary outcomes

  1. Ovulation rate:

    Time frame: 6 months

    detected by folliculometry and midluteal progesterone in serum (higher than 3 ng/mL)

  2. Menstrual cycle regulation

    Time frame: 6 months

    Detection of regulation of the menstrual cycle that is not regular in patients with PCOS assessed as cycle length 21-35 days.

  3. Side effects of both agents

    Time frame: Throughout the study time (up to 1 year).

    Monitoring and recording of any adverse effects experienced by participants during the study period

  4. Ongoing pregnancy rate after the first trimester

    Time frame: first 13 weeks in pregnancy.

    Assessment of the proportion of pregnancies that progress beyond the first trimester

Sponsors and collaborators

Lead sponsor

Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2024
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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