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NCT Number: NCT06793904

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

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.

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Key information

Conditions

Polycystic Ovarian Syndrome (PCOS) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy medical school

Cairo, 12111, Egypt

Location status: Recruiting

Location contact

Ahmed Maged, MD

CONTACT

[email protected]

01005227404

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aromatase inhibitor Letrozole

Drug

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

Primary outcomes

  1. Number of participants with successful ovulation

    Time frame: 5 days after treatment

    the dominant follicle reached 18 or more mm

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Chamel, MD

CONTACT

[email protected]

+20 110 066 2255

Ahmed Maged, MD

CONTACT

[email protected]

01005227404

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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