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

NCT ID: NCT01665547

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Treatment Resistant Disorders

Keywords

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clomiphene resistant pcos induction of ovulation l-carnitine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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l-carnitine

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

Group Type ACTIVE_COMPARATOR

l-carnitine

Intervention Type DRUG

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

Interventions

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l-carnitine

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

Intervention Type DRUG

Other Intervention Names

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carivita,l-carnitol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Woman's Health University Hospital, Egypt

OTHER

Sponsor Role lead

Responsible Party

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alaa eldeen mahmoud ismail

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaa M Ismail, M.D

Role: PRINCIPAL_INVESTIGATOR

Women's Health Hospital

Other Identifiers

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lcpco

Identifier Type: -

Identifier Source: org_study_id