Adding L-carnitine in Clomiphene Resistant Polycystic Ovary Improves the Quality of Ovulation and the Pregnancy Outcome
This study has been completed.
Sponsor:
Woman's Health University Hospital, Egypt
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 20, 2012
Last verified: September 2012
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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 effecacy of l-carnitine in inducing ovulation in clomiphene resistant pco
Secondary Outcome Measures:
- pregnancy [ Time Frame: 0ne year ] [ Designated as safety issue: Yes ]the occurance of pregnancy and the rate of continuation of pregnancy till end of the first trimester
| Enrollment: | 157 |
| Study Start Date: | January 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | January 2012 (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:
The number of stimulated follicles reaching >/=16mm diameter was significantly more in the group A compared to group B(2.1 +/-0.1 vs. 1.1 +/-0.7, p<0.0001). The endometrium at the time of hCG administration was significantly thicker in the group A (10.1+/-0.1mm vs. 9.3+/-0.4mm, p<0.0001). Ovulation occurred in 60/85 cycles (70.5%) in the group A and 35/85 cycles (41.1%) in the group B with a significant difference between two groups in favors of l-carnitine (p=0.01). Serum E(2), on the day of hCG administration, was significantly higher in the l-carnitine group (p<0.0001). Pregnancy occurred in 20/85 cycles in group A (23.5%) and 10/85 cycles (11.7%) in group B and the difference was statistically significant (p=0.04).
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 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 20, 2012 |
| 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 Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Estrogen Antagonists |
Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Fertility Agents, Female Fertility Agents Reproductive Control Agents Therapeutic Uses Selective Estrogen Receptor Modulators |
ClinicalTrials.gov processed this record on May 19, 2013