Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome

NCT ID: NCT03630341

Last Updated: 2018-08-14

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2018-05-31

Brief Summary

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Polycystic ovary syndrome is one of the most common endocrine disorders, affecting about 6-10% of women in their reproductive age. Anovulation and hyperandrogenism are often present together with hyperinsulinaemia and insulin resistance

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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study group

This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral carnitine 1g tablet, three times per day from the third day until the day of the pregnancy test.

Group Type EXPERIMENTAL

Clomiphene Citrate 50mg

Intervention Type DRUG

oral 50 mg tablets

L-carnitine

Intervention Type DRUG

1000 mg oral tablet

control group

This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral placebo tablet, three times per day from the third day until the day of the pregnancy test.

Group Type ACTIVE_COMPARATOR

Clomiphene Citrate 50mg

Intervention Type DRUG

oral 50 mg tablets

Placebo Oral Tablet

Intervention Type DRUG

oral tablets identical to L-carnitine

Interventions

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Clomiphene Citrate 50mg

oral 50 mg tablets

Intervention Type DRUG

L-carnitine

1000 mg oral tablet

Intervention Type DRUG

Placebo Oral Tablet

oral tablets identical to L-carnitine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Primary or secondary infertility.
* Normal Hysterosalpingo-graphy
* Normal Semen analysis of the husband.

Exclusion Criteria

* Patient's refusal.
* Male factors of infertility and/or abnormal Hysterosalpingo-graphy
* Hyperprolactinemia (prolactin ≥ 22 ng/dl).
* FSH on day 3 \> 15 mIU/mL.
* Gross ovarian pathology diagnosed by ultrasound.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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LCCC

Identifier Type: -

Identifier Source: org_study_id

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