Comparing two methods for ovulation induction in infertility treatment
Comparison of Recombinant Follicle Stimulating Hormone and the Combination of Recombinant Follicle Stimulating Hormone With Clomiphene Citrate in Stimulated Intrauterine Insemination Cycles: A Prospective Randomized Controlled Multicentric Study
This study is testing whether using a hormone alone or a mix of hormone and medication helps women with unexplained infertility get pregnant during IUI treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 254 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Bezmialem Vakif University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT05670795 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two different protocols for ovulation induction during intrauterine insemination (IUI) cycles in women with unexplained infertility. Participants will be randomly assigned to receive either recombinant follicle stimulating hormone (rFSH) alone or a combination of rFSH with clomiphene citrate. The study aims to assess pregnancy rates and other reproductive outcomes by collecting data on various factors such as age, BMI, and sperm quality. The goal is to determine which method yields better results for couples facing infertility challenges.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-40 with unexplained infertility and regular menstrual cycles.
Not a fit: Patients with significant ovarian or uterine pathology, or those with severe male factor infertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pregnancy rates for couples struggling with unexplained infertility.
How similar studies have performed: Previous studies have shown promising results with similar ovulation induction protocols, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-40 years old female * Unexplained infertility * Regular menstrual cycle * Bilateral tubal patency in HSG and normal uterine cavity * Total motile sperm count greater than 10 million/ml Exclusion Criteria: * History of ovarian surgery * Uncorrected uterine pathology * Other endocrine diseases (thyroid, prolactin, hypogonadotropic hypogonadism) * Presence of a cyst greater than 10 mm on USG in 2-3 days of the period * Stage 3-4 endometriosis * TMSS \< 5 million/ml on the insemination day * Conditions where rFSH and clomiphene citrate are contraindicated
Where this trial is running
Istanbul
- Bezmialem Vakif University — Istanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: Pinar Ozcan, MD,PhD
- Email: drpinarozcan@hotmail.com
- Phone: +902124531700
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.