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Adding L-carnitine in Clomiphene Resistant Polycystic Ovary Improves the Quality of Ovulation and the Pregnancy Outcome

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier:
NCT01665547
First received: July 13, 2012
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation induction in women with clomiphene resistant PCOS


Condition Intervention Phase
Treatment Resistant Disorders
Drug: l-carnitine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adding L-carnitine in Clomiphene Resistant Pco Improves the Quality of Ovulation and the Pregnancy Outcome,a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Woman's Health University Hospital, Egypt:

Primary Outcome Measures:
  • ovulation induction [ Time Frame: 0ne year ] [ Designated as safety issue: Yes ]
    is to study the efficacy of l-carnitine in inducing ovulation in clomiphene resistant pco


Secondary Outcome Measures:
  • pregnancy [ Time Frame: 0ne year ] [ Designated as safety issue: Yes ]
    the occurrence of pregnancy and the rate of continuation of pregnancy till end of the first trimester


Estimated Enrollment: 157
Study Start Date: July 2012
Estimated Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: l-carnitine
adding 3gm l-carnitine from day 1 to day 12 of induced the menstrual cycle by 50 mg clomiphene
Drug: l-carnitine
3gm l-carnitine from day 1 to day 12 of the menstrual cycle
Other Name: carivita,l-carnitol

Detailed Description:

Patients younger than 35 years, 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 five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included.

  Eligibility

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

Inclusion Criteria:

  • Patients younger than 35 years, 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 five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included. The diagnosis was based on a complete history taking, physical examination and a paper documented complete 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:

  • age more than 40 years,
  • tubal,uterine or male factor infertility
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665547

Sponsors and Collaborators
Woman's Health University Hospital, Egypt
Investigators
Principal Investigator: Alaa M Ismail, M.D Women's Health Hospital
  More Information

No publications provided

Responsible Party: alaa eldeen mahmoud ismail, assistant professor, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT01665547     History of Changes
Other Study ID Numbers: lcpco
Study First Received: July 13, 2012
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Woman's Health University Hospital, Egypt:
clomiphene resistant
pcos
induction of ovulation
l-carnitine

Additional relevant MeSH terms:
Carnitine
Clomiphene
Enclomiphene
Zuclomiphene
Estrogen Antagonists
Estrogen Receptor Modulators
Fertility Agents
Fertility Agents, Female
Growth Substances
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 20, 2014