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NCT03630341 Clinical Trial

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

Polycystic Ovary Syndrome Clinical Trial

Official title:
Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03630341
Other study ID # LCCC
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 1, 2016
Est. completion date May 2018

Study information
Verified date August 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Polycystic ovary syndrome is one of the most common endocrine disorders, affecting about 6-10% of women in their reproductive age. Anovulation and hyperandrogenism are often present together with hyperinsulinaemia and insulin resistance

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date May 2018
Est. primary completion date March 31, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Primary or secondary infertility.

- Normal Hysterosalpingo-graphy

- Normal Semen analysis of the husband.

Exclusion Criteria:

- Patient's refusal.

- Male factors of infertility and/or abnormal Hysterosalpingo-graphy

- Hyperprolactinemia (prolactin = 22 ng/dl).

- FSH on day 3 > 15 mIU/mL.

- Gross ovarian pathology diagnosed by ultrasound.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Clomiphene Citrate 50mg
oral 50 mg tablets
• L-carnitine
1000 mg oral tablet
• Placebo Oral Tablet
oral tablets identical to L-carnitine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary clinical pregnancy rate visible intra-uterine gestational sac, with a positive fetal heart beat, viewed during a transvaginal ultrasound (when the b-hCG concentration was more than 1500 IU/l) 1 month
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