Adding L-carnitine in Clomiphene Resistant Polycystic Ovary Improves the Quality of Ovulation and the Pregnancy Outcome

September 9, 2013 updated by: alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt

Adding L-carnitine in Clomiphene Resistant Pco Improves the Quality of Ovulation and the Pregnancy Outcome,a Randomized Clinical Trial

Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation induction in women with clomiphene resistant PCOS

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included.

Study Type

Interventional

Enrollment (Anticipated)

157

Phase

  • Phase 4

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 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included. The diagnosis was based on a complete history taking, physical examination and a paper documented complete infertility work-up within the previous 6 months, either conducted within the setting of the hospital or at a licensed infertility management clinic.

Exclusion Criteria:

  • age more than 40 years,
  • tubal,uterine or male factor infertility

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: l-carnitine
adding 3gm l-carnitine from day 1 to day 12 of induced the menstrual cycle by 50 mg clomiphene
Drug: l-carnitine
3gm l-carnitine from day 1 to day 12 of the menstrual cycle
Other Names:
  • carivita,l-carnitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ovulation induction
Time Frame: 0ne year
is to study the efficacy of l-carnitine in inducing ovulation in clomiphene resistant pco
0ne year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy
Time Frame: 0ne year
the occurrence of pregnancy and the rate of continuation of pregnancy till end of the first trimester
0ne year

Collaborators and Investigators

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

Sponsor

Woman's Health University Hospital, Egypt

Investigators

  • Principal Investigator: Alaa M Ismail, M.D, Women's Health Hospital

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

July 1, 2012

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (ESTIMATE)

August 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2013

Last Update Submitted That Met QC Criteria

September 9, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • lcpco

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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