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

NCT06793904 | Recruiting DMC

• 2 other identifiers: N 364-2024Cairo university
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Number of participants with successful ovulation

  the dominant follicle reached 18 or more mm

  5 days after treatment

Study Arms (1)

PCOS

EXPERIMENTAL

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.

Drug: Aromatase inhibitor Letrozole

Interventions

Aromatase inhibitor Letrozole DRUG

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

PCOS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: women diagnosed with PCOS
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Ahmed Maged, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

01005227404; dr_ahmedmaged08@kasralainy.edu.eg

Ahmed Chamel, MD

CONTACT

+20 110 066 2255; ahmed-chamel@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 27, 2025
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

EG (1)