IUI With Letrozole Versus in Natural Cycle

NCT04169451 | Recruiting

• 1 other identifier: IUI with/without stimulation
• Study Type: interventional
• Target: 982
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• live birth rate

  Primary outcome is live birth resulting from conception within 4 months after randomization.

  14 months

Study Arms (2)

letrozole group

EXPERIMENTAL

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

natural cycle group

NO INTERVENTION

Women will be given IUI treatment without ovarian stimulation.

Interventions

Letrozole DRUG

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

letrozole group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• The 1st Affiliated Hospital of Anhui Medical University: collaborator
• The 2nd Affiliated Hospital of Hebei Medical University: collaborator
• Tianjin Central Hospitalof Gynecology Obstetrics: collaborator
• Yunnan1stpeople's hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jie Qiao

  Peking Unversity Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Shuo Huang

CONTACT

86-13601203410; homelyleaf@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 19, 2019
• Study Start: September 29, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

CN (1)