IUI With Letrozole Versus in Natural Cycle

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.

Conditions

• Intrauterine Insemination
• Unexplained Infertility

Interventions

DRUG

Letrozole

Women will be randomized to the group with ovarian stimulation with letrozole or the group without stimulation.

Sponsors & Collaborators

• The 1st Affiliated Hospital of Anhui Medical University

  collaborator UNKNOWN

• The 2nd Affiliated Hospital of Hebei Medical University

  collaborator UNKNOWN

• Tianjin Central Hospitalof Gynecology Obstetrics

  collaborator UNKNOWN

• Yunnan1stpeople's hospital

  collaborator UNKNOWN

• Peking University Third Hospital

  lead OTHER

Principal Investigators

• Jie Qiao · Peking Unversity Third Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-29

Primary Completion

2025-12-31

Completion

2026-06-30

Countries

• China

Study Locations