Does Hormonal Luteal Support After Intra-uterine Insemina... | NCT00700492

Studies
Does Hormonal Luteal Support After Intra-uterine Insemination (IUI) Increase the Pregnancy Rate?

NCT00700492

Sponsor

University Hospital, Gasthuisberg

Status

Terminated

Last Update Posted

Jun 25, 2015Estimated

Enrollment

82Actual

Phase

Not Applicable

Conditions

Subfertility

Interventions

progesterone

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

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Change in Belgian law on the use of hMG in IUI

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Mar 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jun 17, 2008

First Submission Date that Met QC Criteria

Jun 17, 2008

First Posted Date

Jun 18, 2008Estimated

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

Jun 24, 2015

Last Update Posted Date

Jun 25, 2015Estimated

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

A randomized study to investigate if hormonal luteal support after intra-uterine insemination (IUI) in ovulation induction cycles with human menopausal gonadotropin increases the pregnancy rate

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	No Intervention
utrogestan	Experimental	daily use of vaginal progesterone capsules	Drug: progesterone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
progesterone	Drug	vaginal capsules 3X200mg daily	utrogestan	Utrogestan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical pregnancy rate per cycle		12 weeks pregnancy

Secondary Outcomes

Measure	Description	Time Frame
rate of miscarriages per cycle		12 weeks pregnancy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Tubal patency demonstrated
ovulation induction with human menopausal gonadotropin

Exclusion Criteria:

ovulation induction with clomiphene citrate

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomad D'Hooghe, MD, PhD	University Hospital Gasthuisberg, Catholic University Leuven, Belgium	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leuven University Fertility Center		Leuven	Vlaams Brabant	3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility
D000022	Abortion, Spontaneous

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011374	Progesterone
C000624167	Utrogestan

Ancestor Terms

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided