Steroid Profiles in PCOS and Effect of OCP Treatment (PCOSLCMS)

Istanbul University

Status: Completed

Conditions: Polycystic Ovary Syndrome (PCOS)

Study type: Observational

Funder types: Other

Identifiers

NCT07161440

PEDENDO-ITF-PCOS-LCMS

Details and patient eligibility

About

This prospective observational study investigates the changes in serum steroid intermediates assessed by liquid chromatography-mass spectrometry (LC-MS/MS) in adolescents and young women with polycystic ovary syndrome (PCOS), before and after oral contraceptive (OCP) treatment.

Full description

The study enrolled 56 female patients aged 13-21 years with a diagnosis of PCOS according to Rotterdam criteria. At baseline, all participants underwent LC-MS/MS steroid profiling. A subgroup of 15 patients received oral contraceptive therapy based on clinical indication, independent of the study protocol. A second LC-MS/MS steroid analysis was performed at 6 months in this subgroup. The primary aim was to investigate the effect of OCP on the steroid biosynthesis profile. The study was approved by the Istanbul University Ethics Committee (Approval ID: 2019/822) and conducted between January 2020 and December 2021.

Enrollment: 56 patients

Sex: Female

Ages: 13 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of PCOS based on Rotterdam criteria
• Age between 13 and 21 years
• No hormonal treatment in the 3 months prior to study enrollment
• Consent provided

Exclusion criteria

• Congenital adrenal hyperplasia
• Cushing's syndrome
• Pregnancy
• Use of hormonal medications within 1 year prior to baseline

Trial design

56 participants in 2 patient groups

PCOS patients without treatment

Description:

This cohort included adolescent patients diagnosed with polycystic ovary syndrome (PCOS) who did not receive any medical treatment during the study period. Steroid hormone levels were measured using LC-MS/MS at baseline for all participants to evaluate the endogenous steroid profile in untreated PCOS.

PCOS patients treated with OCP

Description:

This cohort consisted of adolescent patients with polycystic ovary syndrome (PCOS) who were prescribed oral contraceptive pills (OCP) due to clinical indications. A total of 15 patients from the untreated PCOS group received OCP treatment and were followed for 6 months. Baseline and 6-month serum samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) to evaluate changes in steroid hormone profiles after treatment.