The Role of Progesterone and PIF for Successful Implantat... | NCT02129998

Studies
The Role of Progesterone and PIF for Successful Implantation and On-going Pregnancy in Assisted Reproductive Technology

NCT02129998

Sponsor

Regionshospitalet Viborg, Skive

Status

Completed

Last Update Posted

Oct 9, 2017Actual

Enrollment

873Actual

Phase

Not provided

Conditions

Infertility

Interventions

IVF/ICSI treatment

Countries

Denmark

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

Oct 2017

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

May 2014Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

May 1, 2014

First Submission Date that Met QC Criteria

May 1, 2014

First Posted Date

May 2, 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

Oct 6, 2017

Last Update Posted Date

Oct 9, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Humaidan, Professor, DMSc, Regionshospitalet Viborg, SkivePrincipal Investigator

Lead Sponsor

Regionshospitalet Viborg, SkiveOTHER

Collaborators

Name	Class
Ferring Pharmaceuticals	INDUSTRY
BioIncept LLC	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 aim of this study is to achieve a more profound understanding of the endocrine alteration in luteal progesterone level after gonadotrophin stimulated IVF/ICSI cycles and to explore the optimal progesterone level needed for securing implantation and development of early pregnancy.

The second part of the project will determine the value of Preimplantation Factor (PIF) measurement in embryo culture medium as a possible tool for improved embryo selection and the use of PIF as an early pregnancy serum marker for healthy implantation and embryo development.

IVF: In vitro fertilisation, ICSI: Intracytoplasmic sperm injection.

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

873Actual

Label	Type	Description	Intervention Names
Standard IVF/ICSI treatment			Other: IVF/ICSI treatment

Name	Type	Description	Arm Group Labels	Other Names
IVF/ICSI treatment	Other		Standard IVF/ICSI treatment

Measure	Description	Time Frame
On-going pregnancy rate		10th week of gestation

Measure	Description	Time Frame
Implantation rate		7th week of gestation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-All women undergoing IVF/ICSI treatment at the participating clinics in either antagonist protocol or long agonist protocol will be offered participation.

Exclusion Criteria:

-Prior participation in the study

Accepts Healthy Volunteers

Yes

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

Patients undergoing IVF/ICSI treatment at 4 Danish Fertility Centres.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Fertility Clinic Skive		Skive		7800	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29955789	Derived	Thomsen LH, Kesmodel US, Erb K, Bungum L, Pedersen D, Hauge B, Elbaek HO, Povlsen BB, Andersen CY, Humaidan P. The impact of luteal serum progesterone levels on live birth rates-a prospective study of 602 IVF/ICSI cycles. Hum Reprod. 2018 Aug 1;33(8):1506-1516. doi: 10.1093/humrep/dey226.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases