Cut-Off Progesterone Values Deleterious for In Vitro Fert... | NCT02323347

Studies
Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer

NCT02323347

Sponsor

Fundacion Dexeus

Status

Completed

Last Update Posted

Dec 23, 2014Estimated

Enrollment

1,901Actual

Phase

Not provided

Conditions

Progesterone
Fertilization in Vitro
Infertility
Pregnancy

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

Dec 2014

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

Jan 2009

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Dec 11, 2014

First Submission Date that Met QC Criteria

Dec 22, 2014

First Posted Date

Dec 23, 2014Estimated

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

Dec 22, 2014

Last Update Posted Date

Dec 23, 2014Estimated

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

At which deleterious cut off value of progesterone on day of HCG (P-hCG) in our IVF program should fresh embryo transfer (ET) be cancelled?

Detailed Description

There is still an ongoing debate on the effect of subtle increased P-hCG concentration on pregnancy outcome after fresh ET. No consensus on the cut-off value to define increased P-hCG seems to exist. It is accepted that high P advances endometrium, leading to asynchrony between the implanting embryo and the endometrium, and resulting in implantation failure. A freeze all embryos policy and postponement of ET in subsequent frozen-thawed cycle has been proposed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

1,901Actual

Name	Type	Description	Arm Group Labels	Other Names
Progesterone	Other	Progesterone level

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Pregnancy		6 weeks after embryo transfer procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fresh embryo transfer
Progesterone value on day HCG (Human choriogonadotrophin hormone)

Exclusion Criteria:

Clinical indication for delaying embryo transfer

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Women undergoing IVF-ICSI ad fresh embryo transfer

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26453983	Derived	Martinez F, Rodriguez I, Devesa M, Buxaderas R, Gomez MJ, Coroleu B. Should progesterone on the human chorionic gonadotropin day still be measured? Fertil Steril. 2016 Jan;105(1):86-92. doi: 10.1016/j.fertnstert.2015.09.008. Epub 2015 Oct 9.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473