Comparing single and double intrauterine insemination for male infertility
Double vs Single Intrauterine Insemination in Male Factor Infertility - a Multicenter Randomized Trial
This study is testing whether doing one or two intrauterine insemination procedures can help couples with male infertility get pregnant more successfully.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Umraniye Education and Research Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT05885516 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the pregnancy outcomes of single versus double intrauterine insemination (IUI) in couples facing male factor infertility. The rationale behind double IUI is to enhance the chances of fertilization by increasing the number of motile sperm in the female reproductive tract. The study will recruit 132 participants for each group, focusing on couples with a total motile sperm count between 1-10 million. Participants will be randomized to receive either single or double IUI after ovarian hyperstimulation. The study is designed as a multi-center trial to ensure robust data collection over approximately one year.
Who should consider this trial
Good fit: Ideal candidates are couples trying to conceive for at least 6 months, with the female partner aged 18-40 and the male partner having a total motile sperm count between 1-10 million.
Not a fit: Patients with severe male infertility (TPMSC less than 1 million), female partners over 40, or those with uterine anomalies or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pregnancy rates in couples dealing with male factor infertility.
How similar studies have performed: Previous studies have indicated a need for more high-quality research on this topic, suggesting that while the approach is not entirely novel, it remains inadequately explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Couples trying to conceive for at least 6 months despite of regular sexual intercourse * Female partner between 18-40 years old * Male partner sperm analysis total motile sperm count between 1-10 million in at least 2 sperm analysis on different days. Exclusion Criteria: * No patent fallopian tubes shown in hystero-salpingography * Female partner with a uterine anomaly * History of a previous ovarian surgery * Known or suspected endometriosis in female partner * Body-mass index (BMI) \> 40 kg/m2
Where this trial is running
Istanbul
- Umraniye Training and Research Hospital — Istanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: Merve Dizdar, Speacialist
- Email: mervedizdar@gmail.com
- Phone: +905355962232
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.