Study of Optimal Posology of Gonadotrophins in Patients W... | NCT00575302

Studies
Study of Optimal Posology of Gonadotrophins in Patients With Insufficient Ovarian Response Due to Age

NCT00575302

Sponsor

Centre Hospitalier Chretien

Status

Withdrawn

Last Update Posted

Apr 13, 2010Estimated

Enrollment

400Estimated

Phase

Phase 4

Conditions

Infertility

Interventions

Gonal-f®: follitropin alpha
Gonal-f®: follitropin alpha

Countries

Belgium

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

Apr 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical significance.

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Dec 17, 2007

First Submission Date that Met QC Criteria

Dec 17, 2007

First Posted Date

Dec 18, 2007Estimated

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

Apr 12, 2010

Last Update Posted Date

Apr 13, 2010Estimated

Name	Class
EMD Serono	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

In In vitro fertilization (IVF) treatment, poor responder patients of more than 38 years old are randomized prospectively into two dosages of gonadotrophins. The outcome of treatment will be analyzed.

Detailed Description

Women > 38 years, who had an insufficient response to stimulation with regular (for age) posology of 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol will be randomized prospectively into 2 groups:

300 IU versus 450 IU of Gonal-f® administered in a short agonist protocol. Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.

Patient can be eligible for several cycles in same protocol.

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
300	Active Comparator	administration of 300 IU Gonal-f® in a short agonist protocol.	Drug: Gonal-f®: follitropin alpha
450	Experimental	administration of 450 IU Gonal-f® in a short agonist protocol.	Drug: Gonal-f®: follitropin alpha

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gonal-f®: follitropin alpha	Drug	Gonal-f®: follitropin alpha, administration of 300 U	300

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of mature oocytes		1 month

Secondary Outcomes

Measure	Description	Time Frame
follicular development		1 month
fertilization rate		1 month
implantation rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women > 38 years with insufficient response to stimulation with 225 IU of gonadotrophins (urinary or recombinant), in an agonist protocol.
Insufficient response is defined as: development of ≤ 4 mature follicles (of ≥ 16 mm) at time of hCG administration.
Patient can be eligible for several cycles in same protocol.

Exclusion Criteria:

Patients who already received doses > 225 IU
Patients older than 42 years
Patients with basal FSH concentrations ≥ 15 mU/ml at day 3

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

38 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annick Delvigne, PhD	CHC Saint-Vincent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHC Saint-Vincent		Rocourt	Liège	4000	Belgium
CHU Saint-Pierre

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