Insemination in patients with polycystic ovary syndrome: gestation rates using two stimulation patterns: letrozole vs gonadotropins.

Phase 1

Recruiting

• Conditions: Insemination in patients with polycystic ovary syndrome; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

• Registration Number: CTIS2023-503477-38-00
• Lead Sponsor: Hospital Universitario La Paz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Age: women between 18-40 years old., Body mass index (BMI): =18 and =30., Primary or secondary infertility., Diagnosis of PCOS according to Rotterdam criteria (The Rotterdam ESHRE/ASRM- sponsored PCOS Consensus Workshop Group Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS). Hum Reprod 2004; 19: 41-47)., Insemination indication., Women giving informed consent to participate in the study.

Exclusion Criteria

Women with BMI <18 or >30., Presence of any systemic disease or poorly controlled endocrinological pathology that may interfere with the objectives of the study., Verification by vaginal ultrasound of the presence of any residual follicle or corpus luteum., Patients who have not responded to letrozole in ovulation induction cycles., Contraindication to the use of any of the treatments foreseen by the study in the terms established in the protocol., Women in in vitro fertilization program., Presence of uterine malformations., Presence of polymyomatous uterus, with the exception of subserosal or intramural myomas <5cm that do not deform the uterine cavity., Moderate and severe endometriosis., History or presence of Pelvic Inflammatory Disease., Interventions on cervix that may have originated a stenosis and/or cervical stenosis at the beginning of the study., Unexcised or occluded hydrosalpinx., Existence of severe male factor: cryptozoospermia or oligoasthenoteratozoospermia or with low REM (< 5 million).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified