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
1 other identifier
interventional
110
1 country
1
Brief Summary
The aim of this study was to evaluate the effect of oral L-carnitine supplementation during controlled ovarian stimulation (COS) in patients with polycystic ovary syndrome (PCOS) in a double-blind randomized clinical trial. The eligible patients with PCOS diagnosis (on the basis of Rotterdam criteria) who referred to Royan Research Institute for IVF / ICSI treatment cycles will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 13, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedJune 18, 2023
June 1, 2023
2.8 years
December 13, 2020
June 14, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occyte maturity rate
Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in thepatients undergoing with ICSI.
24 hours post oocyte retrieval day
Secondary Outcomes (5)
Fertilization rate
48 hours post IVF/ICSI
Quality of obtained embryos
48 or 72 hours after oocyte retrieval
Implantation rate
1 month post embryo transfer
Clinical pregnancy rate
6-8 weeks of gestation
ongoing pregnancy rate
20 weeks after the embryos transfer
Study Arms (2)
Adding l-carnitine to controlled ovarian stimulation antagonist protocol
EXPERIMENTALThe 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.
Adding placebo to controlled ovarian stimulation antagonist protocol
PLACEBO COMPARATORThe 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan Institute
Tehran, 16635148, Iran
Related Publications (1)
Hafezi M, Arabipoor A, Ghaffari F, Vesali S, Zareei M, Hessari ZH. Adding L-carnitine to antagonist ovarian stimulation doesn't improve the outcomes of IVF/ ICSI cycle in patients with polycystic ovarian syndrome: a double-blind randomized clinical trial. J Ovarian Res. 2024 Jan 9;17(1):9. doi: 10.1186/s13048-023-01319-7.
PMID: 38191449DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maryam Hafezi, MD.
Department of Endocrinology and Female Infertility, Royan Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- L-carnitine and placebo drugs can be identified only by special codes determined by a statistics specialist. The participant, care provider, investigator and outcome assessor are unaware of the type of study groups.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2020
First Posted
December 17, 2020
Study Start
March 1, 2020
Primary Completion
December 29, 2022
Study Completion
February 28, 2023
Last Updated
June 18, 2023
Record last verified: 2023-06