Clinical Trials Logo

Clinical Trial Summary

Rationale Intrauterine insemination (IUI) is the treatment of first choice for couples with unexplained and mild male factor infertility in many countries, but it is controversial whether ovarian stimulation improves fertility outcomes. In recent retrospectively collected data, we found that in couples with unexplained and mild male factor infertility undergoing IUI, ovarian stimulation with letrozole increased live birth rate as compared to natural cycle IUI without substantially increasing the multiple pregnancy rate. We therefore intend to perform a randomized clinical trial (RCT) on the subject in five reproductive medical centers in different cities in China. Objective To test the hypothesis that in couples with unexplained or mild male factor infertility scheduled for an IUI program ovarian stimulation with letrozole increases the live birth rate as compared to natural cycle treatment. Study design Multicenter randomized controlled trial. Study population Women diagnosed with unexplained or mild male factor infertility scheduled for treatment with IUI. Intervention Women will be randomized for ovarian stimulation with letrozole or to natural cycle IUI. In the group allocated to ovarian stimulation, women will receive oral tablets letrozole 5 mg daily from cycle day 3 for 5 days. We will treat the couples for 3 cycles, with a time horizon of 4 months. Main study parameters/endpoints Primary outcome is live birth resulting from conception within 4 months after randomization. Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy complications, time to pregnancy leading to live birth. Nature and extent of the burden and risks associated with participation, benefit and group relatedness The strategies compared are already broadly applied in current practice. No additional risks are expected. There is no benefit for participants, but the results may benefit future infertile couples.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04169451
Study type Interventional
Source Peking University Third Hospital
Contact Shuo Huang
Phone 86-13601203410
Email homelyleaf@aliyun.com
Status Recruiting
Phase N/A
Start date September 29, 2022
Completion date June 2026

See also
  Status Clinical Trial Phase
Completed NCT01672801 - Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT N/A
Completed NCT01232465 - Impact of Sperm DNA Integrity on In Vitro Cycles N/A
Not yet recruiting NCT01237535 - Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates Phase 4
Completed NCT02272439 - Endocrine Disrupting Chemicals: Potential Effects on Male and Female Reproductive Health in Saskatchewan N/A
Terminated NCT00650754 - Study of Oral Dehydroepiandrosterone(DHEA) to Treat Previously Unexplained Infertility Phase 2/Phase 3
Recruiting NCT04754243 - New Protocol in Unexplained Infertility Phase 4
Completed NCT03018314 - Serum Kisspeptin Levels in Infertile Women N/A
Completed NCT02488434 - The Effects of Using Fertile Chip in Sperm Selection for Intracytoplasmic Sperm Injection in Unexplained Infertility Phase 3
Completed NCT02739516 - Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility Phase 3
Completed NCT02628756 - Endometrial Injury in Women With Unexplained Infertility N/A
Completed NCT01044862 - Assessment of Multiple Intrauterine Gestations From Ovarian Stimulation Phase 3
Recruiting NCT03386552 - A Study of Lidocaine Pertubation as a Treatment for Unexplained Infertility Phase 2
Completed NCT04465045 - Unexplained Infertility Treated by Hysteroscopy-laparoscopy
Completed NCT03461601 - Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility N/A
Completed NCT01859520 - Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa N/A
Active, not recruiting NCT03828786 - Uterine Scratching in Intra-Uterine Insemination N/A
Completed NCT03397693 - Assessment of Endometrial Thickness & Subendometrial Perfusion by 3D Power Doppler in Women With Unexplained Infertility and PCOS.
Withdrawn NCT04955574 - Probiotic and Antibiotic Therapies in Women With Unexplained Infertility Phase 2
Not yet recruiting NCT03398993 - Effect of Endometrial Injury in Couples With Unexplained Infertility N/A
Completed NCT02861105 - The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers Phase 4