se of Myoinositol in patients with Polycystic Ovary Syndrome who will undergo a procedure to try to get pregnant

Phase 3

• Conditions: Polycystic Ovary Syndrome; Insulin Resistance; C12.100.750

• Registration Number: RBR-557c2cz
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-15
• Last Update Posted: 22 July 2024
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Women; between 18 and 40 years of age; with a body mass index between 18 and 34,9 kg/m2; diagnosed with Polycystic Ovary Syndrome according to the Rotterdam criteria; diagnosed with marital infertility according to the World Health Organization criteria; who agree to sign the Term of Free and Informed Consent

Exclusion Criteria

Presence of other diseases that cause hyperandrogenism (non classic congenital adrenal hyperplasia, hyperprolactinemia, thyroid diseases without adequate control, androgen secreting tumors, Cushing's Syndrome); Type 1 diabetes

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is expected to find a 25% increase in the cumulative clinical pregnancy rate, assessed by visualizing an embryo with the presence of a heartbeat in the seventh week of gestation on pelvic ultrasound examination.

Secondary Outcome Measures

Name	Time	Method
Evaluate the improvement in metabolic parameters through serum testosterone, glucose and insulin measurements after three months of medication use. A decrease of at least 5% of the initial value is expected.;An improvement in oocyte quality is expected, assessed following the Istanbul Consensus criteria, with at least 10% more mature oocytes in the experimental group.<br>;A fertilization rate at least 10% higher is expected in the experimental group, with this rate being evaluated by the proportion between the number of oocytes with two pronuclei and two polar bodies over the number of injected oocytes.;An improvement in embryonic quality is expected, assessed following the Istanbul Consensus criteria, with at least 5% more embryos with the best classification.