LE + CC vs. LE for Ovulation Induction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorMỹ Đức Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Women 18-40 years of age
Having ovulation disorder (length of cycle < 21 or > 35 days or having < 8 cycles per year)
FSH ≥5 IU/L and ≤25 IU/L, or LH ≥5 IU/L and AMH ≥1.2 ng/mL
Progressive motility (PR) ≥ 32% OR total progressive motility sperm count > 5 million; and sperm concentration ≥ 5 million/ml, (World Health Organization, 2021)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
IUI or intercourse
Procedure/Surgery5 milligrams LE per day (Femara® 2.5 milligrams, Novartis, Switzerland) and 50 milligrams CC (Duinum 50 milligrams, Medochemie, Cyprus) or 5 milligrams LE per day (Femara® 2.5 milligrams, Novartis, Switzerland) will be started on the second to the fourth day of the cycle, for five consecutive days. An ultrasound will be carried out three days after the last dose of medicine (day 8 of OI) to evaluate ovarian follicles' growth and the endometrium's thickness. If the follicular diameter reach ≥14 millimetres, check-up will be planned every two days until it reaches 18 millimetres. If there is the appearance of at least one follicle reaching 18 millimetres or more, a human chorionic gonadotropin (hCG) injection (IVF-C 5000 IU, LG Life Science, Korea) will be administered on the same day of the ultrasound in order to induce ovulation. IUI will be scheduled 36 - 38 hours after hCG injection or intercourse will be scheduled in the next day.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Combination of LE and CC groupActive comparator 1 intervention
Group B: LE alone groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Live birth after one treatment cycle
Live birth will be defined as the complete expulsion or extraction from a woman of a product of fertilization, after 22 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached.
Time frame
At 22 weeks of gestationSecondary outcomes
1
Duration of stimulation
Duration of stimulation
Time frame
During the intervention2
Number of follicles ≥14mm on day of hCG
Number of follicles ≥14mm on day of hCG
Time frame
During the intervention3
Endometrial thickness on day of hCG
Endometrial thickness on day of hCG
Time frame
During the intervention4
Cycle cancellation
The cycle will be cancelled if (1) there is no follicle reaches ≥18 millimetres) on day 21 of the OI; (2) there are ≥ 3 follicles with diameter ≥16 millimetres or (3) ≥ 4 ovarian follicles with diameter ≥10 millimetres
Time frame
At 21 day of the ovulation induction cycleSponsors and contacts
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Source ClinicalTrials.gov