IUI With Letrozole Versus in Natural Cycle

February 6, 2024 updated by: Jie Qiao, Peking University Third Hospital

Intrauterine Insemination With Letrozole Versus Intrauterine Insemination in Natural Cycle. A Muticenter Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

982

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Shuo Huang, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: letrozole group
Women will be given IUI treatment with ovarian stimulation with letrozole 5mg/day starting from day 3 of menstrual cycle for 5 days.
Drug: Letrozole
Women will be randomized to the group with ovarian stimulation with letrozole or the group without stimulation.
No Intervention: natural cycle group
Women will be given IUI treatment without ovarian stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: 14 months
Primary outcome is live birth resulting from conception within 4 months after randomization.
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

The 1st Affiliated Hospital of Anhui Medical University
The 2nd Affiliated Hospital of Hebei Medical University
Tianjin Central Hospitalof Gynecology Obstetrics
Yunnan1stpeople's hospital

Investigators

  • Study Director: Jie Qiao, Peking Unversity Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 17, 2019

First Submitted That Met QC Criteria

November 17, 2019

First Posted (Actual)

November 19, 2019

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUI with/without stimulation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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