L-carnitine and Metformin in Obese PCOS Women.

Phase 2

Completed

• Conditions: PCOS
• Interventions: Drug: L-carnitine and Metformin; Drug: placebo

• Registration Number: NCT03108963
• Lead Sponsor: Zagazig University

Brief Summary

L-carnitine and plus metformin in clomiphene-resistant obese PCOS women, reproductive and metabolic effect: a randomized clinical trial

Detailed Description

the trial aims to compare L-carnitine and plus metformin in clomiphene-resistant obese PCOS women with placebo to state the reproductive and metabolic effects in form of pregnancy and insulin resistance parameters and lipid metabolism.

Study Timeline

• Study Start: 2017-01
• Status Verified: 2017-04
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-11
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 280

Inclusion Criteria

• pco
• obese
• ifertile

Exclusion Criteria

• no medical disorders
• no hormonal treatment in the previous 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-carnitine and Metformin	L-carnitine and Metformin	L-carnitine and Metformin in Obese PCOS Women trying induction of ovulation with clomiphene citrate.
placebo	placebo	placebo was given toObese PCOS Women trying induction of ovulation with clomiphene citrate.

Primary Outcome Measures

Name	Time	Method
pregnancy rate	3 momths	number of women with clinical pregnancy

Secondary Outcome Measures

Name	Time	Method
ovulation rate	3 momths	number of women with follicle \>18mm.
abortion rate	3 momths	number of women with abortions
insulin resistance	3 momths	fasting glucose and insulin
lipid metabolism	3 momths	Triglyceride, cholesterol

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Egypt