Prolongation of Progesterone Supplementation in Antagonis... | NCT01147770

Studies
Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes

NCT01147770

Sponsor

Universitair Ziekenhuis Brussel

Status

Completed

Last Update Posted

Jul 3, 2013Estimated

Enrollment

200Actual

Phase

Phase 1Phase 2

Conditions

Infertility

Interventions

progesterone

Countries

Not provided

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

Jul 2013

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

Sep 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jun 17, 2010

First Submission Date that Met QC Criteria

Jun 18, 2010

First Posted Date

Jun 22, 2010Estimated

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

Jul 1, 2013

Last Update Posted Date

Jul 3, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 objective of this study is to evaluate the effect of the prolongation of luteal support on the ongoing pregnancy rate (beyond 12 weeks of gestation )in recFSH/GnRH antagonist 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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
stop progesterone	Experimental		Drug: progesterone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
progesterone	Drug	duration	stop progesterone	utrogestan

Measure	Description	Time Frame
ongoing pregnancy rate		up to 2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age equal or less than 39
Body mass index between 18-29 kg/m2
Presence of both ovaries
Basal hormonal values on day 2 of the cycle
Embryotransfer day3 or day5
1 to 3 cycles

Exclusion Criteria:

Endometriosis stage 3
Polycystic ovarian syndrome
Frozen or testicular sperm

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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

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