L-carnitine and Metformin in Obese PCOS Women.

May 1, 2018 updated by: IBRAHIM ABD ELGAFOR, Zagazig University

L-carnitine Plus Metformin in Clomiphene-resistant Obese PCOS Women, Reproductive and Metabolic Effects: a Randomized Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

280

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pco
  • obese
  • ifertile

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-carnitine and Metformin
L-carnitine and Metformin in Obese PCOS Women trying induction of ovulation with clomiphene citrate.
Drug: L-carnitine and Metformin
L-carnitine plus Metformin was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.
Other Names:
  • motova plus and glucphage
Active Comparator: placebo
placebo was given toObese PCOS Women trying induction of ovulation with clomiphene citrate.
Drug: placebo
placebo was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: 3 momths
number of women with clinical pregnancy
3 momths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ovulation rate
Time Frame: 3 momths
number of women with follicle >18mm.
3 momths
abortion rate
Time Frame: 3 momths
number of women with abortions
3 momths
insulin resistance
Time Frame: 3 momths
fasting glucose and insulin
3 momths
lipid metabolism
Time Frame: 3 momths
Triglyceride, cholesterol
3 momths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

April 6, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZUH 6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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