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

Treatment Resistant Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01665547
• Other study ID #: lcpco
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: July 13, 2012
• Last updated: September 9, 2013
• Start date: July 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 157
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Treatment Resistant Disorders

Intervention

Drug:
• l-carnitine
3gm l-carnitine from day 1 to day 12 of the menstrual cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ovulation induction	is to study the efficacy of l-carnitine in inducing ovulation in clomiphene resistant pco	0ne year	Yes
Secondary	pregnancy	the occurrence of pregnancy and the rate of continuation of pregnancy till end of the first trimester	0ne year	Yes