| NCT ID | NCT06934785 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mỹ Đức Hospital |
| Condition | Letrozole |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2025-04-28 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized controlled trial (RCT) aims to evaluate whether, in infertile women with WHO II/IV ovulatory disorders, a combination of letrozole (LE) and clomiphene citrate (CC) compared to LE alone, result in higher live birth rates. The study is designed as an open-label, multicenter RCT across six fertility clinics in Vietnam. Participants will be randomized into two groups: (1) LE + CC , (2) LE alone. The primary outcome measure is the live birth rate after one treatment cycle. Based on prior data, the live birth rate for IUI in letrozole cycles is estimated at 12%. To detect a 10% increase in live birth rates with CC, 436 couples are needed (α = 0.05, power = 80%). Additionally, the live birth rate after IUI with LE-induced ovulation is approximately 18.7% (Diamond et al., 2015). To detect a 10% increase with CC, 560 couples are required (α = 0.05, power = 80%). Considering a 5% loss to follow-up and protocol deviations, the study plans to recruit 600 participants (150 per arm).
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.
Contact & Investigator
Lan N Vuong, PhD,MD
PRINCIPAL INVESTIGATOR
University of Medicine and Pharmacy at Ho Chi Minh City
Frequently Asked Questions
Who can join the NCT06934785 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Letrozole. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06934785 currently recruiting?
Yes, NCT06934785 is actively recruiting participants. Contact the research team at bsvan.ttt@myduchospital.vn for enrollment information.
Where is the NCT06934785 trial being conducted?
This trial is being conducted at Ho Chi Minh City, Vietnam.
Who is sponsoring the NCT06934785 clinical trial?
NCT06934785 is sponsored by Mỹ Đức Hospital. The principal investigator is Lan N Vuong, PhD,MD at University of Medicine and Pharmacy at Ho Chi Minh City. The trial plans to enroll 600 participants.