Trial intelligence / Profile preview

PERCING: Ovarian Drilling vs Medical Treatment in PCOS

NCT00378729Phase 4

Key facts

Status: Unknown
Start: Oct 2006
Primary completion: Oct 2011
Countries: 1
Sponsor: Assistance publique - Hôpitaux de Paris
Modality: Recombinant Proteins and Enzymes, Small Molecules

Drugs: metforminfollitropin alfa
Conditions: polycystic ovary syndrome (PCOS)

Overview

Phase 4, randomised, open-label trial of metformin and follitropin alfa in polycystic ovary syndrome (PCOS) (2 arms), sponsored by Assistance publique - Hôpitaux de Paris. Primary endpoint: Cumulative rate of on-going pregnancy at 9 months. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Medical Treatment
Metformin + FSHr + IUI
Surgical Treatment
Ovarian Drilling

Who it enrols

Patients with PCOS (Rotterdam criteria) aged 18-36 who have failed Clomiphene Citrate treatment. Excludes patients with thyroid disease, virilizing tumors, sperm abnormalities, high prolactin, or tubal obstruction.

Endpoints

Primary

Cumulative rate of on-going pregnancy9 months

Secondary

Evaluation of toleranceduring the study
Occurrence of multiple pregnanciesend of study
Duration of the menstrual cycles and hormonal ovarian dosagesduring the study
Occurrence of spontaneous miscarriagesend of study
Body Mass Indexeach visit

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