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The effect of L-carnitine supplementation on the results of infertility treatment cycle in women with polycystic ovary syndrome

The effect of adding L-carnitine during ovarian stimulation with antagonistic protocol in patients with polycystic ovarian syndrome (PCOS) on the outcome of in-vitro fertilization/intracytoplasmic sperm injection (IVF / ICSI) cycle: A double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080831001141N42
Enrollment
110
Registered
2023-07-19
Start date
2020-03-01
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome disorder. Polycystic ovarian syndrome

Interventions

Intervention 1: In the experimental group: patients receive 3 grams daily (3 tablets of L-carnitine 1000 mg, Karen Pharmaceutical Company, Iran) from the second day of menstruation of the previous cyc

Sponsors

Royan Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 37 Years

Inclusion criteria

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 PCO according to Rotterdam's criteria who had received two to three failures of intrauterine insemination (IUI) cycle therapy were included. The diagnosis was based on a complete history taking, physical examination, and a complete file documented infertility work-up within the previous 6 months, either conducted within the setting of the hospital or at a licensed infertility management clinic.

Exclusion criteria

Exclusion criteria: Patients diagnosed with hyperprolactinemia, diabetes mellitus, epilepsy, and/or any chronic endocrine and cardiovascular diseases Patients are treated with a special diet, medication supplement (ovaboost), and 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 (sperm extraction through surgery)

Design outcomes

Primary

MeasureTime frame
Total number of retrieved oocytes. Timepoint: Day of oocyte pick-up, 32-34 hours after hCG administration (approximately Stimulation Day 10). Method of measurement: At the point of ovum pick-up, we can count the total number of retrieved oocytes. Therefore, in one hour after ovum pick-up, outcome measurement will be possible.;Total number of mature (MII) oocytes. Timepoint: Day of oocyte pick-up, 32-34 hours after hCG administration (approximately Stimulation Day 10). Method of measurement: At the point of ovum pick-up, we can count the total number of mature (MII) oocytes. Therefore, in one hour after ovum pick-up, outcome measurement will be possible.

Secondary

MeasureTime frame
Fertilization rate. Timepoint: 17-18?h after intracytoplasmic sperm injection and/or in-vitro insemination by checking the number of polar bodies and pronuclei. Method of measurement: The fertilization rate was defined as the ratio between the number of diploid zygotes and the number of mature oocytes.;Quality of obtained embryos. Timepoint: 3 days after IVF/ICSI procedure. Method of measurement: Embryo grade was assessed under an inverted microscope 3 days after the intracytoplasmic sperm injection procedure. The quality of embryos was graded from 1 to 3 under inverted microscope 3 days after the intracytoplasmic sperm injection procedure. Embryos with even-sized blastomeres and/or =10% fragments were classified as Grade 1 (Excellent or good quality). Grade 2 embryos (moderate or fair quality) had blastomeres with slightly-moderate size differences and/or 10- 20% fragments. Grade 3 embryos (poor quality) had markedly different-sized blastomeres and/or >20% fragments.;Clinical pregnancy rate. Timepoint: 7 weeks after embryo transfer. Method of measurement: It was defined as the presence of a gestational sac with a heartbeat under vaginal ultrasonography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArezoo Arabipoor

Royan Institute

arezoo.arabipoor@gmail.com+98 21 2356 2640

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026