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
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pregnancy rate:
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Metformin (Drug)
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.
Intervention: pep2dia (Drug)
Outcomes
Primary Outcomes
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
- Menstrual cycle regulation(6 months)
- Ongoing pregnancy rate after the first trimester(first 13 weeks in pregnancy.)
- Ovulation rate:(6 months)
- Side effects of both agents(Throughout the study time (up to 1 year).)
Investigators
Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
lecturer and consultant at Obstetrics and Gynecology Department.
Al-Azhar University