- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03630341
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Endocrine System Diseases
- Disease
- Ovarian Cysts
- Cysts
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Polycystic Ovary Syndrome
- Syndrome
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Estrogen Antagonists
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Clomiphene
- Enclomiphene
- Zuclomiphene
Other Study ID Numbers
- LCCC
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.
Clinical Trials on Polycystic Ovary Syndrome
-
Cairo UniversityCompleted
-
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-
Saudi German Hospital - MadinahCompletedPolycystic Ovary Syndrome (PCOS)Saudi Arabia
-
Assaf-Harofeh Medical CenterUnknownInfertility | Polycystic OvariesIsrael
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Mansoura UniversityNot yet recruitingPCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
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Fundació Sant Joan de DéuRecruitingPolycystic Ovary Syndrome (PCOS)Norway, Austria, Denmark, Italy, Spain, Turkey
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Riphah International UniversityCompleted
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Dexa Medica GroupCompletedPolycystic Ovary Syndrome (PCOS)Indonesia
-
Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...TerminatedPolycystic Ovary Syndrome (PCOS)United States
-
University Magna GraeciaCompletedInfertility | Polycystic Ovary Syndrome (PCOS)Italy
Clinical Trials on Clomiphene Citrate 50mg
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Weill Medical College of Cornell UniversityRecruitingTestosterone DeficiencyUnited States
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Xiyuan Hospital of China Academy of Chinese Medical...Dongzhimen Hospital, Beijing; Beijing Hospital of Traditional Chinese Medicine and other collaboratorsUnknownPolycystic Ovarian Syndrome | Hyperprolactinemia | Anovulatory Infertility | Abnormal Uterine Bleeding-Ovulatory Disorders | Luteinized Unruptured Follicle Syndrome | Corpus Luteum Insufficiency | Ovarian Insufficiency
-
Beni-Suef UniversityCompleted
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Mansoura UniversityCompletedPolycystic Ovary SyndromeEgypt
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Beni-Suef UniversityCompletedSubfertility, FemaleEgypt
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University Magna GraeciaUnknownAnovulatory Infertility Related to Polycystic Ovary SyndromeItaly
-
The Cleveland ClinicWithdrawnInfertility | EndometriosisUnited States