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

August 10, 2018 updated by: Ahmed Mohamed Abbas, Assiut University
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

Study Overview

Study Type

Interventional

Enrollment (Actual)

150

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

No

Genders Eligible for Study

Female

Description

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.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
oral 50 mg tablets
1000 mg oral tablet
ACTIVE_COMPARATOR: 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.
oral 50 mg tablets
oral tablets identical to L-carnitine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 1 month
visible intra-uterine gestational sac, with a positive fetal heart beat, viewed during a transvaginal ultrasound (when the b-hCG concentration was more than 1500 IU/l)
1 month

Collaborators and Investigators

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

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 (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

March 31, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

August 4, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (ACTUAL)

August 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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