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

Phase 4

• Conditions: Treatment Resistant Disorders
• Interventions: Drug: l-carnitine

• Registration Number: NCT01665547
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief Summary

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

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-15
• Primary Completion: 2013-08
• Status Verified: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-09
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 157

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
l-carnitine	l-carnitine	adding 3gm l-carnitine from day 1 to day 12 of induced the menstrual cycle by 50 mg clomiphene

Primary Outcome Measures

Name	Time	Method
ovulation induction	0ne year	is to study the efficacy of l-carnitine in inducing ovulation in clomiphene resistant pco

Secondary Outcome Measures

Name	Time	Method
pregnancy	0ne year	the occurrence of pregnancy and the rate of continuation of pregnancy till end of the first trimester