Actively Recruiting
LE + CC vs. LE for Ovulation Induction
Led by Mỹ Đức Hospital · Updated on 2025-09-11
600
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
LE + CC vs. LE for Ovulation Induction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 40 years
- Diagnosed with WHO Group II/IV ovulatory disorders (menstrual cycle length less than 21 days or more than 35 days, or fewer than 8 cycles per year)
- Partner's sperm with progressive motility of at least 32%, sperm concentration of at least 5 million/ml, and total progressive motile sperm count over 5 million
- Able to provide written informed consent
- Not participating in other studies
You will not qualify if you...
- Untreated thyroid disease, including abnormal TSH levels or positive thyroid antibodies
- Untreated hyperprolactinemia with prolactin levels over 50 ng/mL
- Allergy or contraindications to letrozole or clomiphene citrate
- Unilateral or bilateral fallopian tube blockage confirmed by imaging or surgery
- Untreated endometrial abnormalities such as hyperplasia, adhesions, polyps, or chronic endometritis
- Uterine abnormalities including certain fibroids (L0, L1, L2), severe adenomyosis, or congenital uterine malformations such as didelphus, arcuate, unicornuate, bicornuate, or septate uterus
AI-Screening
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Trial Site Locations
Total: 1 location
1
My Duc Hospital
Ho Chi Minh City, Ho Chi Minh City, Vietnam, 70000
Actively Recruiting
Research Team
V
Van TT Tran, MD
CONTACT
V
Vinh Q Dang, MSc,MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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