Clincosm LogoSign in Get a demo

L-Carnitine and Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT03476356
Collaborator
(none)
106
Enrollment
1
Location
2
Arms
3.9
Actual Duration (Months)
26.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: oral clomiphene citrate
  • Drug: oral carnitine supplementation
 N/A

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.

  1. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
106 participants
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.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)
Masking Description:
One hundred and six opaque envelopes will be numbered serially and, in each envelope, there will be the corresponding letter which denotes the allocated group according to the randomization table. Then all of the envelopes will be closed and they will be placed in one box. When the first woman arrives, the first envelope will be opened and she will be allocated according to the letter inside, and this step will be repeated until the 106 envelopes are finished.
Primary Purpose:
Treatment
Official Title:
L-Carnitine and Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group L

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.

Drug: oral clomiphene citrate
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.
Other Names:
  • clomid

    • Drug: oral carnitine supplementation
    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 Names:
  • Carnitiva Forte

    		•
    Active Comparator: Group C

    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.

    Drug: oral clomiphene citrate
    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.
    Other Names:
  • clomid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ovulation success by trans-vaginal ultrasound [36-48 hours after night of hCG administration]

      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.

    Secondary Outcome Measures

    1. Serum progesterone [Day 8 post hCG injection]

      Serum progesterone will be measured on day 8 post hCG injection, ovulation will be confirmed if the serum progesterone level is ≥ 5 ng/ml.

    2. Clinical pregnancy [14 days after hCG administration]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Age ranging from 18-35 years.

    2. Normal Hysterosalpingo-graphy (HSG).

    3. Normal Semen analysis of the husband.

    4. Diagnosed with PCOS based on the (ESHRE/ASRM) guidelines criteria (Rotterdam Criteria 2003).

    Exclusion Criteria:

    1. Patient's refusal.

    2. Male factors of infertility and/or abnormal HSG.

    3. Hyperprolactinemia (prolactin ≥ 22 ng/dl).

    4. FSH on day 3 > 15 mIU/mL.

    5. Gross ovarian pathology diagnosed by ultrasound.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of obstetrics and gynaecology, faculty of medicine, Ain shams university Cairo Egypt 11591

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rehab Mohamed Abdelrahman, Rehab Mohamed Abdelrahman, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT03476356
    Other Study ID Numbers:
    • PCO L
    First Posted:
    Mar 26, 2018
    Last Update Posted:
    Mar 26, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome
    Clomiphene
    Enclomiphene
    Zuclomiphene

    Study Results

    No Results Posted as of Mar 26, 2018