Comparative Assessment of the Clinical Utility of Ovarian... | NCT01331733

Studies
Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist

NCT01331733

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Apr 8, 2011Estimated

Enrollment

131Actual

Phase

Not provided

Conditions

Sterility

Interventions

hMG-HP
hMG + GnRH antagonist

Countries

Spain

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 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Oct 2008Actual

Completion Date

Mar 2009Actual

First Submitted Date

Apr 6, 2011

First Submission Date that Met QC Criteria

Apr 7, 2011

First Posted Date

Apr 8, 2011Estimated

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 7, 2011

Last Update Posted Date

Apr 8, 2011Estimated

Name	Class
Ferring SAU	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

To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination.

Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist should be more effective than monotherapy.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

131Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hMG-HP		Patients with a condition	Drug: hMG-HP
hMG-HP + GnRH antagonist		Patients with a condition	Drug: hMG + GnRH antagonist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hMG-HP	Drug		hMG-HP
hMG + GnRH antagonist

Measure	Description	Time Frame
Clinical pregnancy rate		30 days

Measure	Description	Time Frame
Live birth rate		40 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged 18-36 years
Body mass index (BMI) between 18 and 26
Prolactin within the laboratory normal range
Couples affected by sterility able to treat by IUI (intrauterine insemination)
Patients undergoing Menopur® treatment
Normal thyroid function
Regular menses (21-35 days)
Couples willing to participate in the study that have signed the informed consent form
Seminal sample REM>3 million

Exclusion Criteria:

Two previous ART (assisted reproductive technology) cycles without ongoing pregnancy
Policystic ovarian syndrome
Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

36 Years

Standard Ages

Adult

Study Population

Females affected by sterility able to undergo intrauterine insemination

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Development Support	Ferring Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational site		Barcelona	Barcelona		Spain
Investigational site

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