NCT01665547

Brief Summary

Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation induction in women with clomiphene resistant PCOS

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
157

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2012

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

1.1 years

First QC Date

July 13, 2012

Last Update Submit

September 9, 2013

Conditions

Treatment Resistant Disorders

Keywords

clomiphene resistantpcosinduction of ovulationl-carnitine

Outcome Measures

Primary Outcomes (1)

  • ovulation induction

    is to study the efficacy of l-carnitine in inducing ovulation in clomiphene resistant pco

    0ne year

Secondary Outcomes (1)

  • pregnancy

    0ne year

Study Arms (1)

l-carnitine

ACTIVE COMPARATOR

adding 3gm l-carnitine from day 1 to day 12 of induced the menstrual cycle by 50 mg clomiphene

Drug: l-carnitine

Interventions

l-carnitineDRUG

3gm l-carnitine from day 1 to day 12 of the menstrual cycle

Also known as: carivita,l-carnitol
l-carnitine

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included. The diagnosis was based on a complete history taking, physical examination and a paper documented complete infertility work-up within the previous 6 months, either conducted within the setting of the hospital or at a licensed infertility management clinic.

You may not qualify if:

  • age more than 40 years,
  • tubal,uterine or male factor infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Alaa M Ismail, M.D

    Women's Health Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 13, 2012

First Posted

August 15, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

September 10, 2013

Record last verified: 2013-09