TNF Polymorphism and Implantation Rate | NCT02806934

Studies
TNF Polymorphism and Implantation Rate

NCT02806934

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Jun 21, 2016Estimated

Enrollment

120Actual

Phase

Not provided

Conditions

Infertility

Interventions

biological and ultrasound test

Countries

France

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 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

Jun 2009

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

May 27, 2016

First Submission Date that Met QC Criteria

Jun 20, 2016

First Posted Date

Jun 21, 2016Estimated

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 20, 2016

Last Update Posted Date

Jun 21, 2016Estimated

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

Do TNF-308 and -238 polymorphisms impact the embryo implantation rate after in vitro fertilization (IVF) in women without female infertility factor ?

Detailed Description

This study was performed in order to verify whether TNF-308 allele was associated with a higher implantation rate and multiple pregnancy rates in women without known infertility factors after ovarian hyperstimulation with exogenous FSH for IVF

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

120Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biological and ultrasound test	Procedure	biological and ultrasound test 20 days after implantation in order to see the implantation rate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implantation rate by biological test		20 days after implantation
Implantation rate by ultrasound test		20 days after implantation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women
normal karyotype,
age under 38 years
serum follicle-stimulating hormone (Day-3 FSH) levels below 10 UI/l

Exclusion Criteria:

age under 18 years

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

37 Years

Standard Ages

Adult

Study Population

Women undergoing intracytoplasmic sperm injection (ICSI) due to male infertility factors

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick FENICHEL, PU-PH	service d'Endocrinologie	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nice University Hospital		Nice		06000	France

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
D001688	Biological Products
D019220	High-Energy Shock Waves

Ancestor Terms

ID	Term
D045424	Complex Mixtures
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing

Browse Leaves

Not provided

Browse Branches

Not provided