Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
FEMALE
ID06934785

Combination of Letrozole and Clomiphene Citrate Versus Letrozole Alone for Ovulation Induction in Women With WHO Group II/IV Ovulatory Disorders: A Randomized Controlled Trial

Led by Mỹ Đức Hospital · Updated on 2025-09-11

600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether combining letrozole (LE) and clomiphene citrate (CC) leads to higher live birth rates compared to letrozole alone in infertile women with WHO II/IV ovulatory disorders. This open-label, multicenter randomized controlled trial involves six fertility clinics in Vietnam and aims to clarify the potential benefit of combining these two ovulation induction drugs with different mechanisms of action. Participants are randomly assigned to receive either a combination of 5 milligrams letrozole and 50 milligrams clomiphene citrate per day or letrozole alone, starting on the second to fourth day of their menstrual cycle for five consecutive days. Ovulation is monitored by ultrasound, and if at least one follicle reaches 18 millimeters, a human chorionic gonadotropin (hCG) injection is administered to induce ovulation. Intrauterine insemination (IUI) or natural intercourse is then scheduled accordingly. During the study, participants undergo hormone and biochemical blood tests, ultrasound evaluations of ovarian follicles and endometrial thickness, and pregnancy monitoring up to 22 weeks gestation to assess live birth rates. Additional outcomes such as ovulation rates, pregnancy tests, gestational complications, and birth outcomes are also tracked. The study plans to recruit 600 women aged 18 to 40 and will collect data throughout one treatment cycle with close follow-up and safety monitoring.

CONDITIONS

Brief Title

LE + CC vs. LE for Ovulation Induction

Who Can Participate

Age: 18Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 40 years
  • Diagnosed with WHO II/IV ovulatory disorders (menstrual cycle length less than 21 or more than 35 days or fewer than 8 cycles per year)
  • Partner's sperm with progressive motility ≥ 32%, sperm concentration ≥ 5 million/ml, and total progressive motile sperm count > 5 million
  • Provided written informed consent
  • Not currently participating in other studies
Not Eligible

You will not qualify if you...

  • Untreated thyroid disease or abnormal thyroid hormone levels (TSH ≥ 4 mIU/L or TSH ≥ 2.5 mIU/L with positive thyroid antibodies, or TSH < 0.1 mIU/L)
  • Untreated hyperprolactinemia (prolactin > 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, severe adenomyosis, or congenital uterine malformations

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) on the day ovulation induction starts

Treatment

Duration - One ovulation induction cycle (approximately 2 weeks)

Participants receive ovulation induction medication with either a combination of Letrozole and Clomiphene Citrate or Letrozole alone, starting on day 2 to 4 of their menstrual cycle for five consecutive days. Ultrasound monitoring is performed to evaluate follicle growth and timing of ovulation trigger, followed by intrauterine insemination (IUI) or timed intercourse.

1 to 3 visits: ultrasound on day 8 of ovulation induction, then every two days until ovulation trigger, plus scheduling of IUI or intercourse

Follow-up

Duration - Up to 22 weeks of gestation

Participants are monitored for pregnancy outcomes including live birth and any pregnancy-related events up to delivery.

Periodic assessments during pregnancy based on clinical care

Trial Site Locations

Total: 1 location

1

My Duc Hospital

Ho Chi Minh City, Ho Chi Minh City, Vietnam, 70000

Actively Recruiting

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Research Team

V

Van TT Tran, MD

V

Vinh Q Dang, MSc,MD

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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Published Research Related To This Trial

Recommendations From the 2023 International Evidence-based Guideline for the Assessment and Management of Polycystic Ovary Syndrome.

Helena J Teede, Chau Thien Tay, Joop J E Laven...

https://pubmed.ncbi.nlm.nih.gov/37580314

Gonadotrophins versus clomifene citrate with or without intrauterine insemination in women with normogonadotropic anovulation and clomifene failure (M-OVIN): a randomised, two-by-two factorial trial.

Nienke S Weiss, Marleen J Nahuis, Esmee Bordewijk...

https://pubmed.ncbi.nlm.nih.gov/29273245

A randomized controlled trial of combination letrozole and clomiphene citrate or letrozole alone for ovulation induction in women with polycystic ovary syndrome.

Rachel B Mejia, Karen M Summers, Jessica D Kresowik...

https://pubmed.ncbi.nlm.nih.gov/30683591