L-carnitine and COH in PCOS Women Undergoing IVF/ICSI Cycles
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

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.
    

Detailed description: 
      The study protocol was approved by the Institutional Review Board and Ethics Committee of
      Royan institute. Prior to the onset of ovarian stimulation, patients will be allocated
      randomly into two groups according to block randomization method. The methodologist will give
      the doctor a code according to the randomization list, which corresponds to the code on the
      drug's box, and the drug box will be delivered to the patient. The COS 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 received 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. The patients in control group will receive 3
      placebo tablets for 8 weeks. All the placebo tablets were produced by Karen company (Tehran,
      Iran), which is approved by the Food and Drug Administration of Iran. The appearance of the
      placebo was indistinguishable in color, shape, size, and smell from L-carnitine tablets.
      Ovarian stimulation will start with a maximum dose of 150 units of rFSH (Gonal -F: Serono
      Laboratories Ltd, Geneva, Switzerlan), from the second or third day of the spontaneous or
      discontinued progesterone menstrual cycle and the monitoring transvaginal ultrasound was
      performed and then if the follicle is observed, start with 13 injections of GnRH antagonist
      (Cetrotide®, 0.25 mg cetrorelix acetate, Serono, Inc) and will be continued until the oocyte
      triggering day. From the seventh day of the cycle, the dose of rFSH will be determined
      according to the rate of ovarian response by vaginal ultrasonography two days in advance. If
      you see at least two follicles 18 mm in size or more, the final stimulation of oocyte
      maturation will be done and 34- 36 hour after that the ovum pickup will be conducted.
      Subsequently ICSI or IVF will be done with standard procedure. In the present study, the
      markers of insulin metabolism (fasting glucose and insulin) and lipid profiles (LDL, HDL,
      cholesterol and triglyceride) as well as body mass index and weight were measured at the
      baseline of the study (before starting L-carnitine supplementation) as well as 6 weeks later
      on the ovum pick up day.The outcome evaluators were also blinded to the random allocation
      process and type of treatment.The primary and secondary outcomes were compared between the
      two groups using appropriate statistical tests.
    

Intervention name(s): L-carnitine 1000 Mg
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Quaternary ammonium compound
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: L-carnitine; Assisted reproductive technology; Controlled ovarian stimulation