- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04672720
L-carnitine and COH in PCOS Women Undergoing IVF/ICSI Cycles
The Effect of Adding L-carnitine During Ovarian Stimulation With Antagonistic Protocol in Patients With Polycystic Ovarian Syndrome on the Outcome of IVF / ICSI Cycle: A Double Blind Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Parvaneh Afsharian, Ph.D
- Phone Number: +982123562674
- Email: pafshar@royaninstitiute.org
Study Locations
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Tehran, Iran, Islamic Republic of, 16635148
- Royan Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Patients between 20 to 37 years old, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam's criteria who had received two to three failures of IUI cycle therapy 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
Exclusion Criteria:
- Patients diagnosed with hyperprolactinemia, diabetes mellitus, epilepsy
- Patients treated with special diet, medication supplement (ovuboost), metformin before or during ovarian stimulation
- History of pelvic surgery on ovaries and uterus.
- Presence of submucosal and intramural fibroids larger than 5 cm or the presence of uterine polyps and congenital uterine malformations.
- The cause of severe male infertility (TESE, PESA).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adding l-carnitine to controlled ovarian stimulation antagonist protocol
The controlled ovarian stimulation procedure in all the study participate will be same by using a flexible regimen of GnRH antagonist with E2 priming.
In the experimental group, the women will receive 3 tablet of L-carnitine daily (L-carnitine® tablet 1000 mg, Karen Pharmaceutical Company, Iran) from day 2 of the previous menstrual cycle until pregnancy test day.
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Prescription 3mg l-carnitine (L-carnitine® tablet 1000 mg, Karen Pharmaceutical Company, Iran) daily from day 2 of the previous menstrual cycle until pregnancy test day (approximately 8 weeks).
Other Names:
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Placebo Comparator: Adding placebo to controlled ovarian stimulation antagonist protocol
The controlled ovarian stimulation procedure in all the study participate will be same by using a flexible regimen of GnRH antagonist with E2 priming.
The patients in the control group will receive 3 placebo tablets in similar way for 8 weeks.
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Prescription 3mg l-carnitine (L-carnitine® tablet 1000 mg, Karen Pharmaceutical Company, Iran) daily from day 2 of the previous menstrual cycle until pregnancy test day (approximately 8 weeks).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occyte maturity rate
Time Frame: 24 hours post oocyte retrieval day
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Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in thepatients undergoing with ICSI.
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24 hours post oocyte retrieval day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fertilization rate
Time Frame: 48 hours post IVF/ICSI
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Fertilization rate was defined as the ratio of normal fertilized oocytes (2PNs) to the number of oocytes used for fertilization.
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48 hours post IVF/ICSI
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Quality of obtained embryos
Time Frame: 48 or 72 hours after oocyte retrieval
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Embryo quality were determined according to the number of cells, the amount of fragmentation, the variation in cell size and overall symmetry (perfect, moderately asymmetric, and severely asymmetric in size and shape of the cells at Day 2 or Day 3 after oocyte retrieval: Excellent (Day 3: 6-8 even size blastomeres with ≤10% fragmentation), Good (Day 3: 6-8 even or uneven size blastomeres with 10%-20% fragmentation), Poor (Uneven and few blastomeres with >20% fragmentation) |
48 or 72 hours after oocyte retrieval
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Implantation rate
Time Frame: 1 month post embryo transfer
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The number of gestational sacs observed at trans-vaginal ultrasonography screening at 6 weeks of pregnancy divided by the number of embryos transferred.
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1 month post embryo transfer
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Clinical pregnancy rate
Time Frame: 6-8 weeks of gestation
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Clinical pregnancy rate per transfer as defined by the presence of a gestational sac with heart beat on ultrasound at 6-8 weeks of gestation
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6-8 weeks of gestation
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ongoing pregnancy rate
Time Frame: 20 weeks after the embryos transfer
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Ongoing pregnancy was defined as a pregnancy documented by ultrasound at 20 gestational weeks that showed the presence of fetal heartbeat.
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20 weeks after the embryos transfer
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maryam Hafezi, MD., Department of Endocrinology and Female Infertility, Royan Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Polycystic Ovary Syndrome
- Syndrome
Other Study ID Numbers
- L-carnitine - PCOS- ART
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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