Trial intelligence / Profile preview

L-carnitine Plus Metformin in Clomiphene-resistant Obese PCOS Women

NCT03108963Phase 2

Key facts

Status
Completed
Start
Jan 2017
Primary completion
Mar 2018
Countries
1
Sponsor
Zagazig University
Modality
Small Molecules
Conditions
polycystic ovary syndrome (PCOS)
01

Overview

Phase 2, randomised trial in polycystic ovary syndrome (PCOS) comparing L-carnitine and Metformin with Placebo (2 arms). Primary endpoint: Pregnancy rate at 3 months. Started Jan 2017; status: completed.

02

Design

2 arms
Study design
Randomized
  • L-carnitine and Metformin

    L-carnitine and Metformin in Obese PCOS Women trying induction of ovulation with clomiphene citrate.

  • Placebo

    Placebo given to Obese PCOS Women trying induction of ovulation with clomiphene citrate.

03

Who it enrols

Obese, infertile women with clomiphene-resistant PCOS, with no other medical disorders and no hormonal treatment in the previous 3 months.

04

Endpoints

Primary

  • Pregnancy rate

Secondary

  • Ovulation rate

  • Abortion rate

  • Insulin resistance parameters

  • Lipid metabolism parameters

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