Status:
RECRUITING
LE + CC vs. LE for Ovulation Induction
Lead Sponsor:
Mỹ Đức Hospital
Conditions:
Letrozole
Clomiphene Citrate
Eligibility:
FEMALE
18-40 years
Phase:
NA
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...
Detailed Description
Letrozole (LE) has been suggested as a first-line treatment for ovulation induction in PCOS. Clomiphene citrate (CC) is another widely used drug to induce ovulation in women with PCOS. Due to the diff...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06934785
Start Date
April 28 2025
End Date
June 30 2027
Last Update
September 11 2025
Active Locations (1)
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1
My Duc Hospital
Ho Chi Minh City, Ho Chi Minh City, Vietnam, 70000