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Search / Trial NCT04169451

IUI With Letrozole Versus in Natural Cycle

Launched by PEKING UNIVERSITY THIRD HOSPITAL · Nov 17, 2019

Trial Information

Current as of April 30, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a treatment called intrauterine insemination (IUI) combined with a medication called letrozole in women who have unexplained infertility or mild male infertility. The goal is to see if using letrozole, which helps stimulate the ovaries to produce eggs, can increase the chances of having a baby compared to IUI without any medication. The trial will involve women from five different cities in China and will follow them over a period of four months.

To be eligible for the trial, women must have a diagnosis of unexplained infertility or mild male infertility and have at least one healthy fallopian tube. They should also have normal or slightly reduced sperm quality. Women with certain conditions, like irregular menstrual cycles or significant issues with their partner's sperm, will not be able to participate. Participants will be randomly assigned to either take letrozole or go through the IUI process without it. While there are no additional risks expected from participating, the findings from this study could help future couples struggling with infertility.

Gender

FEMALE

Eligibility criteria

  • 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

About Peking University Third Hospital

Peking University Third Hospital is a leading medical institution in China, renowned for its commitment to advanced healthcare, innovative research, and comprehensive clinical services. As a prominent sponsor of clinical trials, the hospital emphasizes the integration of cutting-edge scientific research with patient-centered care to enhance therapeutic outcomes. With a multidisciplinary approach, the institution fosters collaboration among top-tier medical professionals and researchers, striving to contribute to the global medical community through rigorous clinical studies that address pressing health challenges. Its dedication to ethical standards and regulatory compliance ensures the safety and efficacy of new treatments, ultimately aiming to improve patient care and outcomes on both a national and international scale.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Jie Qiao

Study Director

Peking Unversity Third Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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