LE + CC vs. LE for Ovulation Induction With and Without IUI

Launched by MỸ ĐỨC HOSPITAL · Apr 12, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the best ways to help women who have difficulty ovulating and want to become pregnant. Specifically, it is comparing two treatments: a combination of two medications called letrozole (LE) and clomiphene citrate (CC) versus using letrozole alone. It is also examining whether adding a procedure called intrauterine insemination (IUI)—where sperm is placed directly in the uterus—makes a difference compared to just timed intercourse. The goal of the study is to see which approach leads to more live births after treatment.

To participate in this trial, women aged 18 to 40 who have certain ovulation problems may be eligible. This includes women with irregular menstrual cycles or fewer than eight cycles a year. Participants will be divided into four groups and can expect to follow a treatment plan for one cycle, after which the researchers will check the results. It's important to note that the study is not yet recruiting participants, and women with certain medical conditions or those who are unable to have intercourse may not qualify. Overall, this trial aims to find effective ways to help women achieve pregnancy.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women 18-40 years of age
• • Having WHO II/IV ovulatory disorders (length of cycle \< 21 or \> 35 days or having \< 8 cycles per year)
• • Progressive motility (PR) ≥ 32%, sperm concentration ≥ 5 million/ml, total progressive motility sperm count \> 5 million (World Health Organization, 2021)
• • Written informed consent.
• • Not participating in other studies.
• Exclusion Criteria:
• • Untreated thyroid disease; Thyroid disease is suspected if patients have one of these (Bednarczuk et al., 2021); TSH ≥4 mIU/L or TSH ≥2.5mIU/L and TPOAb (+) or TSH \<0.1mIU/L
• • Untreated hyper-prolactinemia; Hyperprolactinemia is suspected if patients have prolactinemia concentration \>50 ng/mL (The sample is collected after an overnight fast, at least 2 hours after waking up, ensuring that venipuncture does not cause excessive stress.)
• • Allergy or having contraindications to LE or CC;
• • Unilateral or Bilateral fallopian tube blockage (HSG, HyFoSy or surgery confirmation)
• • Untreated endometrial abnormalities include endometrial hyperplasia, intrauterine adhesions, endometrial polyp, or chronic endometritis.
• • Uterine abnormalities include leiomyomas L0, L1, or L2; severe adenomyosis; congenital uterine abnormalities, include didelphus, arcuate, unicornuate, bicornuate, septate.
• • Patients were unable to have intercourse and will be indicated for IUI