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

NCT03630341 | Completed Phase 4

• 1 other identifier: LCCC
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

study group

EXPERIMENTAL

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.

Drug: Clomiphene Citrate 50mg; Drug: L-carnitine

control group

ACTIVE COMPARATOR

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.

Drug: Clomiphene Citrate 50mg; Drug: Placebo Oral Tablet

Interventions

Clomiphene Citrate 50mg DRUG

oral 50 mg tablets

control group; study group

L-carnitine DRUG

1000 mg oral tablet

study group

Placebo Oral Tablet DRUG

oral tablets identical to L-carnitine

control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary or secondary infertility.
• Normal Hysterosalpingo-graphy
• Normal Semen analysis of the husband.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Clomiphene; Carnitine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 4, 2018
• First Posted: August 14, 2018
• Study Start: February 1, 2016
• Primary Completion: March 31, 2018
• Study Completion: May 1, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share