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Status unknownNCT01665547Updated Sep 10, 2013

Adding L-carnitine in Clomiphene Resistant Polycystic Ovary Improves the Quality of Ovulation and the Pregnancy Outcome

A Phase 4 interventional study of l-carnitine in Treatment Resistant Disorders, sponsored by Woman's Health University Hospital, Egypt. Status unknown. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-10.

Sponsored by Woman's Health University Hospital, Egypt · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
157
Allocation
Not applicable
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Treatment Resistant Disorders

Keywords

  • clomiphene resistant
  • pcos
  • induction of ovulation
  • l-carnitine
03

In context

Lead sponsor

Woman's Health University Hospital, Egypt is the lead sponsor of 46 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • age more than 40 years,
  • tubal,uterine or male factor infertility
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
157 participants (estimated)

Study arms

  • Active comparator
    l-carnitine

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

    Drug: l-carnitine

Interventions

  • Drugl-carnitine

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

    Also known as: carivita,l-carnitol

06

What researchers measure

Primary outcomes

  1. ovulation induction

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

    Time frame: 0ne year

Secondary outcomes

  1. pregnancy

    the occurrence of pregnancy and the rate of continuation of pregnancy till end of the first trimester

    Time frame: 0ne year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01665547
Lead sponsor
Woman's Health University Hospital, Egypt
Responsible party
alaa eldeen mahmoud ismail (assistant professor, Woman's Health University Hospital, Egypt) — Principal investigator
First posted
Aug 15, 2012
Start date
Jul 2012
Primary completion
Aug 2013
Completion
Sep 2013 (estimated)
Last update
Sep 10, 2013

Study contacts

Alaa M Ismail, M.D
principal investigator · Women's Health Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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