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

PCOS Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452511
• Other study ID #: Azhar524
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: June 2024
• Source: Al-Azhar University
• Contact: Muhamed Alhagrasy
• Phone: 01017313413
• Email: MuhamedAhmed.216[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• PCOS

Intervention

Drug:
• Metformin
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
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.

Locations

Country	Name	City	State
Egypt	Al-Hussein University Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate:	detected by positive pregnancy test in serum (Chemical pregnancy) or presence of intrauterine gestational sac (Clinical pregnancy)	6 months
Secondary	Ovulation rate:	detected by folliculometry and midluteal progesterone in serum (higher than 3 ng/mL)	6 months
Secondary	Menstrual cycle regulation	Detection of regulation of the menstrual cycle that is not regular in patients with PCOS assessed as cycle length 21-35 days.	6 months
Secondary	Side effects of both agents	Monitoring and recording of any adverse effects experienced by participants during the study period	Throughout the study time (up to 1 year).
Secondary	Ongoing pregnancy rate after the first trimester	Assessment of the proportion of pregnancies that progress beyond the first trimester	first 13 weeks in pregnancy.