Human Chorionic Gonadotropin Supplementation Prior to In-... | NCT01205009

Studies
Human Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders

NCT01205009

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Mar 2, 2011Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Infertility

Interventions

Ovitrelle

Countries

Israel

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 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Mar 2012Estimated

Completion Date

Not provided

First Submitted Date

Aug 30, 2010

First Submission Date that Met QC Criteria

Sep 16, 2010

First Posted Date

Sep 20, 2010Estimated

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

Mar 1, 2011

Last Update Posted Date

Mar 2, 2011Estimated

Description Module

Brief Summary

In an era of delayed fertility plans, there is increasing need for fertility treatment in older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ovitrelle supplemantation	Active Comparator	The women will be given 250 mcg of Ovitrelle prior to their IVF cycle	Drug: Ovitrelle
no Ovitrelle supplementation	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ovitrelle	Drug	One dose of Ovitrelle 250 mcg	Ovitrelle supplemantation

Measure	Description	Time Frame
number of oocytes retrieved		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women >39 years on IVF treatment

Exclusion Criteria:

polycystic ovary syndrome
Any allergy to injection of human chorionic gonadotropin before

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mushira Aboo Dia,, MD	Contact			mushiraa@gmail.com
Hadas Lemberg, PhD	Contact	00 972 2 6777572		lhadas@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Mushira Aboo Dia, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Center		Jerusalem	Israel		Israel

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006063	Chorionic Gonadotropin

Ancestor Terms

ID	Term
D006062	Gonadotropins
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Browse Leaves

Not provided

Browse Branches

Not provided