Clinical trial NCT06452511: Comparing the Effect of Metformin vs. Pep2dia as an Adjunct to Letrozole on Ovulation Induction and Pregnancy Outcomes in Overweight Women With PCOS
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: PCOS
Keywords: PCOS
Metformin
Pep2dia
overweight
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy rate:
timeFrame: 6 months
Secondary outcomes:
measure: Ovulation rate:
timeFrame: 6 months
measure: Menstrual cycle regulation
timeFrame: 6 months
measure: Side effects of both agents
timeFrame: Throughout the study time (up to 1 year).
measure: Ongoing pregnancy rate after the first trimester
timeFrame: first 13 weeks in pregnancy.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Hussein University Hospital
Study officials:
References: