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Letrozole Extended vs Traditional Therapy for Ovulation Induction in Women With PCOS (PROLEx-PCOS)

ConditionsPCOS (Polycystic Ovary Syndrome)InfertilityAnovulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorGABRIEL MONTEIRO PINHEIRO

About this trial

This randomized clinical trial aims to compare the efficacy and safety of extended letrozole therapy (5 mg/day for 10 days) versus standard letrozole therapy (5 mg/day for 5 days) for ovulation induction in women with polycystic ovary syndrome (PCOS). A total of 84 women aged 18-40 years will be randomized into two groups. Ovulation will be monitored by transvaginal ultrasound and confirmed with urinary LH testing and/or corpus luteum presence. The primary outcome is ovulation rate, while secondary outcomes include number and size of mature follicles, clinical pregnancy rate, multiple pregnancy rate, miscarriage rate, number of cycles until pregnancy, and incidence of ovarian hyperstimulation syndrome (OHSS).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women aged 18 to 40 years;

BMI between 18,5 and 31 kg/m2

Diagnosis of Polycystic Ovary Syndrome (PCOS) according to the Rotterdam criteria (2003) (presence of at least two of the following: oligo/anovulation, clinical and/or biochemical hyperandrogenism, polycystic ovarian morphology on ultrasound);

Active desire for pregnancy at the time of enrollment;

Disqualifiers

Age <18 or >40 years;

Presence of confirmed bilateral tubal factor, severe male factor infertility, premature ovarian insufficiency, uncontrolled hyperprolactinemia or thyroid dysfunction);

Congenital or acquired uterine malformations;

History of gynecologic or breast cancer;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Traditional Letrozole Therapy

    Drug

    Traditional therapy group: 5 mg/day of letrozole for 5 days (cycle days 2-6).

  • Extended Letrozole Therapy

    Drug

    Extended therapy group: 5 mg/day of letrozole for 10 days (cycle days 2-12)

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Traditional Letrozole TherapyActive comparator 1 intervention
Group B: Extended Letrozole TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ovulation rate

Proportion of participants achieving ovulation, defined as the presence of a dominant follicle ≥18 mm on transvaginal ultrasound with confirmation by urinary LH surge and/or visualization of corpus luteum.

Time frame
Assessed within one treatment cycle (up to 6 weeks from the start of medication).

Secondary outcomes

1

Clinical Pregnancy Rate

Proportion of participants achieving clinical pregnancy, defined as visualization of a gestational sac by transvaginal ultrasound.

Time frame
Assessed within 8 weeks after the start of treatment.
2

Number of Mature Follicles

Number of follicles ≥18 mm observed by transvaginal ultrasound in the stimulated cycle.

Time frame
Assessed during one treatment cycle (up to 6 weeks).
3

Follicular Size

Maximum diameter (in millimeters) of the leading follicle(s) observed by transvaginal ultrasound.

Time frame
Assessed during one treatment cycle (up to 6 weeks).
4

Miscarriage Rate

Proportion of participants with spontaneous pregnancy loss within the first trimester (\<12 weeks of gestation).

Time frame
Assessed up to 12 weeks of gestation.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GABRIEL MONTEIRO PINHEIRO

Lead sponsor

EMBRIONARE

Sponsor institution

Source ClinicalTrials.gov
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