NCT02522806

Brief Summary

In spite of all progress realized in the field of assisted reproduction the pregnancy rate by In vitro fertilization (IVF) in France, across indications, is only 23% after IVF cycle. Different causes may account for these failures and that, during all stages of pregnancy. Recent studies have investigated an essential step in fecundation : uterine receptivity. Some teams have shown that a lot of immunological factors would have very significant in this step, by them possible expression in this process. Other studies looked at genes modulation, essential to implantation, with endometrium manipulation, simple, such as endometrial biopsy (EB). The last findings published on this subject, but after 2 IVF failures, are most encouraging because the pregnancy rate for these teams after just endometrial local injury (EB after 2 IVF failures) is well above their usual pregnancy rate. Some teams have focused on immunoassay of endometrial biopsy, in order to profile uterine receptivity and suggest with results, suitable treatment for each patient (ongoing study). EB is quick, easy, make in a simple consultation and with a low cost, contrary to immunological study, which depend of ultra-specialized laboratories and therefore with an important cost.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
315

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

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

September 23, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

4.5 years

First QC Date

August 12, 2015

Last Update Submit

November 14, 2019

Conditions

Sterility, Female

Keywords

Endometrial biopsyprevious ovarian hyperstimulation cyclefirst IVFantagonist protocolclinical pregnancy rate

Outcome Measures

Primary Outcomes (1)

  • number of Early pregnancy

    Early pregnancy is defined by beta human chorionic gonadotropin (HCG)\>100 mIU/ml defined by at least one rate of beta HCG\>100 on the 3 possible dosages after embryo transfer (if first dosage negative or \>100 : stop, if first dosage positive but \<100 : Second dosing, if \>100 or less than first result : stop, otherwise third dosing). Endometrial biopsy (diameter : 1mm ; length : 5mm) with use a pipelle, in the second part of the cycle between J17 and J22 during cycle before IVF

    Day 28

Secondary Outcomes (7)

  • Number of middle pregnancy

    5 weeks of amenorrheas.

  • Number of late pregnancy

    12 weeks of amenorrheas.

  • number of Live birth

    delivery

  • number of patient with endometrial chronic infection

    Day 22 of previous cycle of IVF

  • number of patient with pain

    Day 22 of previous cycle of IVF

  • +2 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle.

Procedure: endometrial biopsy

Group B

NO INTERVENTION

none endometrial biopsy

Interventions

endometrial biopsyPROCEDURE

Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle

Group A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Only first IVF
  • Acceptance of protocol by patient after free and complete information and signature of consent.
  • Anti-Mullerian Hormone (AMH ) greater than 1
  • Member or eligible to social security system
  • Availabilities for a follow up 2 or 12 months.

You may not qualify if:

  • Known intolerance of proposed treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Anne GENOD, MD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2015

First Posted

August 13, 2015

Study Start

September 23, 2014

Primary Completion

April 10, 2019

Study Completion

April 10, 2019

Last Updated

November 18, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)