Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS

NCT ID: NCT06793904

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-01-31

Brief Summary

122 women diagnosed with PCOS seeking fertility in the fertility clinic at kasr Alainy hospital will be subjected to Homeostatic model assessment for insulin resistance 1 was calculated for all participants through the equation [glucose (mmol/L) × insulin (µU/L)]/22.5 while homeostatic model assessment for insulin resistance 2 was calculated by the HOMA2 calculator. All women will be subjected to induction of ovulation using the Aromatase inhibitor Letrozole 2.5 mg tab twice daily from the 3rd day of the cycle for 5 days . Ultrasound follow up of follicular growth will be performed till dominant follicular size reaches 18-22 mm. FSH preparations will be introduced as needed.

Conditions

Polycystic Ovarian Syndrome (PCOS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PCOS

Homeostatic model assessment for insulin resistance 1 will be calculated for all participants through the equation \[glucose (mmol/L) × insulin (µU/L)\]/22.5 while homeostatic model assessment for insulin resistance 2 will be calculated by the HOMA2 calculator. All women will be subjected to induction of ovulation using the Aromatase inhibitor Letrozole 2.5 mg tab twice daily from the 3rd day of the cycle for 5 days . Ultrasound follow up of follicular growth will be performed till dominant follicular size reaches 18-22 mm. FSH preparations were introduced as needed.

Group Type: EXPERIMENTAL

Aromatase inhibitor Letrozole

Intervention Type: DRUG

2.5 mg tab twice daily from the 3rd day of the cycle for 5 days

Interventions

Aromatase inhibitor Letrozole

2.5 mg tab twice daily from the 3rd day of the cycle for 5 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18-35 years
• duration of infertility 1-4 years
• PCOS

Exclusion Criteria

women with other causes of infertility (tubal factor assessed by laparoscopy or hysterosalpingogram, uterine cavity abnormality assessed by ultrasound or hysteroscopy or male factor assessed by seme analysis),

• endometriosis,
• ovarian cysts,
• endocrinological abnormalities (Diabetes mellitus, hypothalamic, pituitary or thyroid disorders, or hyperprolactinemia),
• women with history of poor ovarian response or ovarian hyperstimulation
• women with chronic diseases, chromosomal, autoimmune or coagulation defects, abnormal leucocytic count or other inflammatory markers
• Women with contraindications to pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kasr Alainy medical school

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Maged, MD

Role: CONTACT

dr_ahmedmaged08@kasralainy.edu.eg

01005227404

Ahmed Chamel, MD

Role: CONTACT

ahmed-chamel@hotmail.com

+20 110 066 2255

Facility Contacts

Ahmed Maged, MD

Role: primary

prof.ahmedmaged@gmail.com

01005227404

Other Identifiers

Cairo university

Identifier Type: OTHER

Identifier Source: secondary_id

N 364-2024

Identifier Type: -

Identifier Source: org_study_id