Comparing two methods to predict ovulation outcomes in women with PCOS
Comparative Study Between HOMA1-IR and HOMA2-IR in Prediction of Ovulation Outcome in Women With PCOS: A Prospective Cohort Study
This study is testing two different methods to see which one better predicts ovulation success in women with PCOS who are trying to get pregnant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06793904 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two different homeostatic model assessments for insulin resistance (HOMA1-IR and HOMA2-IR) in predicting ovulation outcomes in women diagnosed with Polycystic Ovarian Syndrome (PCOS) who are seeking fertility treatment. A total of 122 participants will undergo insulin resistance assessments and will be treated with the aromatase inhibitor Letrozole to induce ovulation. Ultrasound monitoring will track follicular growth until the dominant follicle reaches the appropriate size for ovulation. The study aims to determine which assessment method provides better predictive outcomes for ovulation.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-35 with a diagnosis of PCOS and a history of infertility lasting 1-4 years.
Not a fit: Patients with other infertility causes, chronic diseases, or contraindications to pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve ovulation prediction and fertility treatment strategies for women with PCOS.
How similar studies have performed: Previous studies have shown varying success with similar approaches in assessing insulin resistance and fertility outcomes, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo
- Kasr Alainy medical school — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmed Maged, MD — Cairo University
- Study coordinator: Ahmed Maged, MD
- Email: dr_ahmedmaged08@kasralainy.edu.eg
- Phone: 01005227404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.