L-Carnitine and Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of the study to assess the efficacy of adding L-carnitine to clomiphene citrate
      for increasing the ovulation and the pregnancy rate in women with PCOS.
    

Detailed description: 
      A total of 106 women with the diagnosis of PCOS based on the European Society of Human
      Reproduction and Embryology/ American Society for Reproductive Medicine (ESHRE/ASRM)
      guidelines criteria (Rotterdam Criteria, 2003) will be randomly assigned using a
      computer-generated randomization sheet and they will be distributed into two groups:

        1. Group L (53 patients):

           This group will receive oral clomiphene citrate (Clomid, Global Napi Pharmaceuticals
           (GNP), Egypt) (50 mg tablet, two times per day) from the third day of the cycle until
           the seventh day of the cycle plus oral carnitine supplementation (Carnivita Forte, Eva
           Pharma, Egypt) (1g tablet, three times per day) from the third day of the cycle until
           the day of the pregnancy test.

        2. Group C (53 patients):

      This group will receive oral clomiphene citrate only (Clomid, Global Napi Pharmaceuticals
      (GNP), Egypt) (50 mg tablet, two times per day) from the third day of the cycle until the
      seventh day of the cycle. Serum FSH, LH & free testosterone concentrations will be measured
      on day 3 (basal) of the cycle. Trans-vaginal folliculometry will be performed on all women on
      days 7 and 9 of the cycle and then individualized according to the response. When one leading
      follicle attains a diameter of 17mm or more, the endometrial thickness will be measured and
      10,000 IU of Human chorionic gonadotropin (hCG) will be given (im injection; Pregnyl,
      organon, Holland). Timed intercourse will be advised after 36-48 hours from the night of hCG
      administration for 2 successive days. Ovulation success will be confirmed by transvaginal
      ultrasound which will show that the leading follicle has collapsed, and some fluid appeared
      in the Douglas pouch.

      Serum progesterone will be measured on day 8 post hCG injection, ovulation will be confirmed
      if the serum progesterone level is ≥ 5 ng/ml (Leiva et al., 2015).

      Luteal-phase support will not be provided in both groups. Pregnancy test will be done in the
      form of testing the level of beta hCG in the blood after 14 days once the success of the
      ovulation process has been confirmed.
    

Intervention name(s): oral clomiphene citrate; oral carnitine supplementation
Intervention type(s): Drug; Drug
Intervention description(s): oral clomiphene citrate 50 mg tablet, two times per day will be received from the third day of the cycle until the seventh day of the cycle.; oral carnitine supplementation 1g tablet, three times per day will be received from the third day of the cycle until the day of the pregnancy test.
Other intervention name(s): clomid; Carnitiva Forte
Intervention MeSH terms: Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 106 women with the diagnosis of PCOS based on the European Society of Human Reproduction and Embryology/ American Society for Reproductive Medicine (ESHRE/ASRM) guidelines criteria (Rotterdam Criteria, 2003) will be randomly assigned using a computer-generated randomization sheet and they will be distributed into two groups:
Group L (53 patients):
This group will receive oral clomiphene citrate (Clomid, Global Napi Pharmaceuticals (GNP), Egypt) (50 mg tablet, two times per day) from the third day of the cycle until the seventh day of the cycle plus oral carnitine supplementation (Carnivita Forte, Eva Pharma, Egypt) (1g tablet, three times per day) from the third day of the cycle until the day of the pregnancy test.
Group C (53 patients):
This group will receive oral clomiphene citrate only (Clomid, Global Napi Pharmaceuticals (GNP), Egypt) (50 mg tablet, two times per day) from the third day of the cycle until the seventh day of the cycle.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment