NCT02806934

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
Last Updated

June 21, 2016

Status Verified

June 1, 2016

Enrollment Period

4.5 years

First QC Date

May 27, 2016

Last Update Submit

June 20, 2016

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

  • Implantation rate by biological test

    20 days after implantation

  • Implantation rate by ultrasound test

    20 days after implantation

Interventions

biological and ultrasound testPROCEDURE

biological and ultrasound test 20 days after implantation in order to see the implantation rate

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice University Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Infertility

Interventions

Biological ProductsHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Complex MixturesUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Patrick FENICHEL, PU-PH

    service d'Endocrinologie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 21, 2016

Study Start

June 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 21, 2016

Record last verified: 2016-06

Locations

FR(1)