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

A

Assiut University

Status and phase

Completed
Phase 4

Conditions

Polycystic Ovary Syndrome

Treatments

Drug: Placebo Oral Tablet
Drug: L-carnitine
Drug: Clomiphene Citrate 50mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03630341
LCCC

Details and patient eligibility

About

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

Enrollment

150 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

150 participants in 2 patient groups

study group
Experimental group
Description:
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.
Treatment:
Drug: Clomiphene Citrate 50mg
Drug: L-carnitine
control group
Active Comparator group
Description:
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.
Treatment:
Drug: Clomiphene Citrate 50mg
Drug: Placebo Oral Tablet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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