Intrauterine Insemination With Letrozole Versus Without Stimulation

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

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 and results from a pilot study, investigators 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. Investigators therefore perform a randomized clinical trial (RCT) on the subject in the Centre of Reproductive Medicine, Peking University Third Hospital, Beijing, 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 IUI without stimulation.

Study design Randomized clinical 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 3-5 for 5 days. Investigators will treat the couples for 3 cycles, with a time horizon of 4 months.

Main study parameters/endpoints Primary outcome is ongoing pregnancy leading to live birth. Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy complications and patients' costs.

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 subfertile couples.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Third Hospital
• Treatments: Letrozole

Criteria

Inclusion 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 sperm concentration above 5 million per millilitre or progressive motility sperm no less than 10%, based on at least one recent semen analysis

Exclusion Criteria:

• Woman with double sided tubal pathology

• Women with irregular cycles, PCOS or other endocrine disorders

• Man with impaired semen quality: sperm concentration lower than 5 million per millilitre or progressive motility sperm less than 10%

• Women younger than 20 years old