Skip to main content
OpenTrials
Completed

NCT Number: NCT03630341

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clomiphene Citrate 50mg

Drug

oral 50 mg tablets

L-carnitine

Drug

1000 mg oral tablet

Placebo oral tablet

Drug

oral tablets identical to L-carnitine

Primary outcomes

  1. clinical pregnancy rate

    Time frame: 1 month

    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)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.