Assessment of the Effectiveness of Menopur in Intrauterin... | NCT01354834

Studies
Assessment of the Effectiveness of Menopur in Intrauterine Insemination

NCT01354834

Sponsor

Ferring Pharmaceuticals

Status

Completed

Last Update Posted

Mar 28, 2025Actual

Enrollment

207Actual

Phase

Not provided

Conditions

Infertility

Interventions

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

May 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

Mar 2004

Primary Completion Date

Dec 2005Actual

Completion Date

Apr 2006Actual

First Submitted Date

May 16, 2011

First Submission Date that Met QC Criteria

May 16, 2011

First Posted Date

May 17, 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

Mar 27, 2025

Last Update Posted Date

Mar 28, 2025Actual

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

The purpose of this study is to assess the effectiveness of Menopur to achieve clinical pregnancy in females undergoing intrauterine insemination in clinical practice.

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

207Actual

Label	Type	Description	Intervention Names
hMG			Drug: hMG

Name	Type	Description	Arm Group Labels	Other Names
hMG	Drug	Patients with a condition	hMG

Measure	Description	Time Frame
Clinical pregnancy rate		30 days

Measure	Description	Time Frame
Live birth rate		40 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infertile couples for over one year (primary or secondary) or infertile women (or not) with indication of PAI or DAI
Seminal sample suitable for artificial insemination treatment according to the criterion of each centre
Patient prescribed therapy with Menopur in artificial insemination

Exclusion Criteria:

Contraindications to intrauterine insemination
Contraindications to Menopur

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Females affected by infertility 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		Elche	Alicante		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