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

NCT03476356 | Completed DMC

• 1 other identifier: PCO L
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study to assess the efficacy of adding L-carnitine to clomiphene citrate for increasing the ovulation and the pregnancy rate in women with PCOS.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Ovulation success by trans-vaginal ultrasound

  Ovulation success will be confirmed by transvaginal ultrasound which will show that the leading follicle has collapsed, and some fluid appeared in the Douglas pouch.

  36-48 hours after night of hCG administration

Secondary Outcomes (2)

• Serum progesterone

  Day 8 post hCG injection

• Clinical pregnancy

  14 days after hCG administration

Study Arms (2)

Group L

EXPERIMENTAL

This group will receive oral clomiphene citrate (Clomid, Global Napi Pharmaceuticals (GNP), Egypt) (50 mg tablet, two times per day) from the third day of the cycle until the seventh day of the cycle plus oral carnitine supplementation (Carnivita Forte, Eva Pharma, Egypt) (1g tablet, three times per day) from the third day of the cycle until the day of the pregnancy test.

Drug: oral clomiphene citrate; Drug: oral carnitine supplementation

Group C

ACTIVE COMPARATOR

This group will receive oral clomiphene citrate only (Clomid, Global Napi Pharmaceuticals (GNP), Egypt) (50 mg tablet, two times per day) from the third day of the cycle until the seventh day of the cycle.

Drug: oral clomiphene citrate

Interventions

oral clomiphene citrate DRUG

oral clomiphene citrate 50 mg tablet, two times per day will be received from the third day of the cycle until the seventh day of the cycle.

Also known as: clomid

Group C; Group L

oral carnitine supplementation DRUG

oral carnitine supplementation 1g tablet, three times per day will be received from the third day of the cycle until the day of the pregnancy test.

Also known as: Carnitiva Forte

Group L

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age ranging from 18-35 years.
• Normal Hysterosalpingo-graphy (HSG).
• Normal Semen analysis of the husband.
• Diagnosed with PCOS based on the (ESHRE/ASRM) guidelines criteria (Rotterdam Criteria 2003).

You may not qualify if:

• Patient's refusal.
• Male factors of infertility and/or abnormal HSG.
• Hyperprolactinemia (prolactin ≥ 22 ng/dl).
• FSH on day 3 \> 15 mIU/mL.
• Gross ovarian pathology diagnosed by ultrasound.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Department of obstetrics and gynaecology, faculty of medicine, Ain shams university

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Clomiphene

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: One hundred and six opaque envelopes will be numbered serially and, in each envelope, there will be the corresponding letter which denotes the allocated group according to the randomization table. Then all of the envelopes will be closed and they will be placed in one box. When the first woman arrives, the first envelope will be opened and she will be allocated according to the letter inside, and this step will be repeated until the 106 envelopes are finished.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rehab Mohamed Abdelrahman

Model Details: A total of 106 women with the diagnosis of PCOS based on the European Society of Human Reproduction and Embryology/ American Society for Reproductive Medicine (ESHRE/ASRM) guidelines criteria (Rotterdam Criteria, 2003) will be randomly assigned using a computer-generated randomization sheet and they will be distributed into two groups: Group L (53 patients): This group will receive oral clomiphene citrate (Clomid, Global Napi Pharmaceuticals (GNP), Egypt) (50 mg tablet, two times per day) from the third day of the cycle until the seventh day of the cycle plus oral carnitine supplementation (Carnivita Forte, Eva Pharma, Egypt) (1g tablet, three times per day) from the third day of the cycle until the day of the pregnancy test. Group C (53 patients): This group will receive oral clomiphene citrate only (Clomid, Global Napi Pharmaceuticals (GNP), Egypt) (50 mg tablet, two times per day) from the third day of the cycle until the seventh day of the cycle.

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 26, 2018
• Study Start: November 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 26, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)