Assessment of the Therapeutic Utility of r-FSH in Associa... | NCT01330771

Studies
Assessment of the Therapeutic Utility of r-FSH in Association With hMG-HP

NCT01330771

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Apr 7, 2011Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Sterility

Interventions

hMG-HP/r-FSH

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

Oct 2006

Primary Completion Date

Jun 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Apr 6, 2011

First Submission Date that Met QC Criteria

Apr 6, 2011

First Posted Date

Apr 7, 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 6, 2011

Last Update Posted Date

Apr 7, 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 a protocol of ovarian hyperstimulation combining urinary gonadotrophins + recombinant gonadotrophins, to achieve clinical pregnancy in females undergoing IVF.

Study hypothesis: to assess the effectiveness of protocols combining urinary gonadotrophins + recombinant gonadotrophins

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

51Actual

Label	Type	Description	Intervention Names
hMG-HP/r-FSH		Patients with a condition	Drug: hMG-HP/r-FSH

Name	Type	Description	Arm Group Labels	Other Names
hMG-HP/r-FSH	Drug		hMG-HP/r-FSH

Measure	Description	Time Frame
Clinical pregnancy rate		30 days

Measure	Description	Time Frame
Biochemical pregnancy rate		16 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women aged 18-38 years
Body mass index (BMI) between 18 and 30
Women classified as normogonadotrophin patients. Not more than 3 previous cycles of ART (assisted reproductive technology)
Testosterona, FSH (follicle-stimulating hormone), LH (luteinizing hormone) and Prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range
No administration of clomiphen citrate or gonadotropins during the month prior to the start of the study

Exclusion Criteria:

Failure in previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
Seminal samples not apt for IVF-ICSI (according to the criteria of each center). Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
Data suggestive of possible ovarian failure
Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
Important systemic disease
Pregnancy or contraindication to pregnancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Females affected by sterility able to undergo IVF

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		Valencia	Valencia		Spain

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases