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Trial record 27 of 571 for:    "Polycystic Ovary Syndrome"

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

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ClinicalTrials.gov Identifier: NCT03476356
Recruitment Status : Completed
First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
Rehab Mohamed Abdelrahman, Ain Shams University

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
Polycystic Ovary Syndrome Drug: oral clomiphene citrate Drug: oral carnitine supplementation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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.

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 : November 1, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018


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 Name: 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 Name: 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 Name: clomid




Primary Outcome Measures :
  1. Ovulation success by trans-vaginal ultrasound [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476356


Locations
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Egypt
Department of obstetrics and gynaecology, faculty of medicine, Ain shams university
Cairo, Egypt, 11591
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Rehab Mohamed Abdelrahman, Ain Shams University
ClinicalTrials.gov Identifier: NCT03476356     History of Changes
Other Study ID Numbers: PCO L
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: L-Carnitine and Clomiphene Citrate for induction of ovulation in women with Polycystic Ovary Syndrome

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators