Comparing Letrozole with Natural Cycle for Intrauterine Insemination
Intrauterine Insemination With Letrozole Versus Intrauterine Insemination in Natural Cycle. A Muticenter Randomized Controlled Trial
This study tests if using letrozole to stimulate ovaries can help couples with unexplained infertility or mild male factor infertility have a baby through IUI, compared to doing it naturally.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 982 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04169451 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of ovarian stimulation with letrozole compared to natural cycle intrauterine insemination (IUI) in couples facing unexplained infertility or mild male factor infertility. The study will be conducted as a multicenter randomized controlled trial across five reproductive medical centers in China. The primary objective is to determine if letrozole increases the live birth rate without significantly raising the risk of multiple pregnancies. Couples meeting specific eligibility criteria will be enrolled to assess the outcomes of the two treatment approaches.
Who should consider this trial
Good fit: Ideal candidates include couples diagnosed with unexplained infertility or mild male factor infertility who have at least one patent fallopian tube and normal or mildly impaired semen quality.
Not a fit: Patients with double-sided tubal pathology, irregular cycles, or significant male infertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance fertility outcomes for couples struggling with unexplained infertility.
How similar studies have performed: Previous studies have suggested that ovarian stimulation may improve live birth rates in similar populations, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria In order to be eligible to participate in this study, a participating couple must meet all of the following criteria: * Being diagnosed with unexplained or mild male infertility * At least one sided tubal patency, established according to local protocol * Normal or mild impairment of semen quality defined as total motile sperm count (TMSC) no less than 5million, based on at least one recent semen analysis Exclusion criteria A potential participant who meets any of the following criteria will be excluded from study participation: * Woman with double sided tubal pathology * Women with irregular cycles, PCOS or other endocrine disorders * Man with impaired semen quality: total motile sperm count (TMSC) less than 5million
Where this trial is running
Beijing, Beijing Municipality
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Shuo Huang
- Email: homelyleaf@aliyun.com
- Phone: 86-13601203410
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.