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

Cairo University (CU)

Status: Enrolling

Conditions: Polycystic Ovarian Syndrome (PCOS)

Treatments: Drug: Aromatase inhibitor Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT06793904

Cairo university

N 364-2024

Details and patient eligibility

About

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.

Enrollment: 122 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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122 participants in 1 patient group

PCOS

Experimental group

Description:

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.

Treatment:

Drug: Aromatase inhibitor Letrozole