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

Assiut University150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Polycystic Ovary Syndrome

Interventions

Clomiphene Citrate 50mgDRUG

oral 50 mg tablets

L-carnitineDRUG

1000 mg oral tablet

Placebo Oral TabletDRUG

oral tablets identical to L-carnitine

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: 1 month

Data from ClinicalTrials.gov

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