GnRH Agonist and Intrauterine Insemination | NCT00503217

Studies
GnRH Agonist and Intrauterine Insemination

NCT00503217

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status

Completed

Last Update Posted

Sep 7, 2016Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Intrauterine Insemination

Interventions

Tryptorelin

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

Sep 2016

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

Feb 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Jul 17, 2007

First Submission Date that Met QC Criteria

Jul 17, 2007

First Posted Date

Jul 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

Sep 5, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jose Bellver, Gynecologist IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIAPrincipal Investigator

Lead Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIAOTHER

Collaborators

Not provided

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 aim of this study is to assess whether GnRH agonist administration in the luteal phase improves pregnancy outcome in intrauterine insemination (IUI) cycles.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Tryptorelin	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women < 38 years old
Bilateral tubal patency confirmed by hysterosonography
Normal ultrasound scan of uterus and ovaries
Normal day 3 basal hormones
Motile sperm count after capacitation ≥ 3 mill/ml

Exclusion Criteria:

Endometriosis
Polycystic ovary syndrome
Uterine disease (polyps, myomas and müllerian diseases)

Accepts Healthy Volunteers

Yes

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose Bellver, MD	Instituto Valenciano de la Infertilidad	Principal Investigator
Elena Labarta, MD	Instituto Valenciano de Infertilidad	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Valenciano de Infertilidad Spain		Valencia	Valencia	46015	Spain