Back to resultsAdding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Clomiphene Citrate 50mg
L-carnitine
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
clinical pregnancy rate
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03630341
Brief Title
Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome
Official Title
Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate 50mg
Intervention Description
oral 50 mg tablets
Intervention Type
Drug
Intervention Name(s)
L-carnitine
Intervention Description
1000 mg oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
oral tablets identical to L-carnitine
Primary Outcome Measure Information:
Title
clinical pregnancy rate
Description
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)
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome
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