Adding L-carnitine in Clomiphene Resistant Polycystic Ova... | NCT01665547

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

NCT01665547

Sponsor

Woman's Health University Hospital, Egypt

Status

Unknown status

Last Update Posted

Sep 10, 2013Estimated

Enrollment

157Estimated

Phase

Phase 4

Conditions

Treatment Resistant Disorders

Interventions

l-carnitine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Sep 2013Estimated

First Submitted Date

Jul 13, 2012

First Submission Date that Met QC Criteria

Aug 9, 2012

First Posted Date

Aug 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2013

Last Update Posted Date

Sep 10, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

alaa eldeen mahmoud ismail, assistant professor, Woman's Health University Hospital, EgyptPrincipal Investigator

Lead Sponsor

Woman's Health University Hospital, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

157Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
l-carnitine	Drug	3gm l-carnitine from day 1 to day 12 of the menstrual cycle	l-carnitine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ovulation induction	is to study the efficacy of l-carnitine in inducing ovulation in clomiphene resistant pco	0ne year

Secondary Outcomes

Measure	Description	Time Frame
pregnancy	the occurrence of pregnancy and the rate of continuation of pregnancy till end of the first trimester	0ne year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alaa M Ismail, M.D	Women's Health Hospital	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002331	Carnitine

Ancestor Terms

ID	Term
D050337	Trimethyl Ammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided