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

Assiut University

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Placebo Oral Tablet; Drug: L-carnitine; Drug: Clomiphene Citrate 50mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03630341

LCCC

Details and patient eligibility

About

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

Enrollment: 150 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

study group

Experimental group

Description:

This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral carnitine 1g tablet, three times per day from the third day until the day of the pregnancy test.

Treatment:

Drug: Clomiphene Citrate 50mg

Drug: L-carnitine

control group

Active Comparator group

Description:

This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral placebo tablet, three times per day from the third day until the day of the pregnancy test.

Treatment:

Drug: Clomiphene Citrate 50mg

Drug: Placebo Oral Tablet