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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03476356
• Other study ID #: PCO L
• Status: Completed
• Phase: N/A
• First received: March 19, 2018
• Last updated: March 19, 2018
• Start date: November 1, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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:

1. 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.

2. 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. Serum FSH, LH & free testosterone concentrations will be measured on day 3 (basal) of the cycle. Trans-vaginal folliculometry will be performed on all women on days 7 and 9 of the cycle and then individualized according to the response. When one leading follicle attains a diameter of 17mm or more, the endometrial thickness will be measured and 10,000 IU of Human chorionic gonadotropin (hCG) will be given (im injection; Pregnyl, organon, Holland). Timed intercourse will be advised after 36-48 hours from the night of hCG administration for 2 successive days. 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.

Serum progesterone will be measured on day 8 post hCG injection, ovulation will be confirmed if the serum progesterone level is ≥ 5 ng/ml (Leiva et al., 2015).

Luteal-phase support will not be provided in both groups. Pregnancy test will be done in the form of testing the level of beta hCG in the blood after 14 days once the success of the ovulation process has been confirmed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

1. Age ranging from 18-35 years.

2. Normal Hysterosalpingo-graphy (HSG).

3. Normal Semen analysis of the husband.

4. Diagnosed with PCOS based on the (ESHRE/ASRM) guidelines criteria (Rotterdam Criteria 2003).

Exclusion Criteria:

1. Patient's refusal.

2. Male factors of infertility and/or abnormal HSG.

3. Hyperprolactinemia (prolactin = 22 ng/dl).

4. FSH on day 3 > 15 mIU/mL.

5. Gross ovarian pathology diagnosed by ultrasound.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• oral clomiphene citrate
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.
• oral carnitine supplementation
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.

Locations

Country	Name	City	State
Egypt	Department of obstetrics and gynaecology, faculty of medicine, Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum progesterone	Serum progesterone will be measured on day 8 post hCG injection, ovulation will be confirmed if the serum progesterone level is = 5 ng/ml.	Day 8 post hCG injection
Secondary	Clinical pregnancy	Pregnancy test will be done in the form of testing the level of beta hCG in the blood after 14 days once the success of the ovulation process has been confirmed.	14 days after hCG administration