CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 190 enrolled
Drug / intervention
biopsy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01064193
NCT01064193Phase 3Completed
CompareCT.gov

Influence of Local Biopsy of the Endometrium Prior to Controlled Ovarian Stimulation for IVF or ICSI Procedure on the Rates of Embryo Implantation, Clinical Pregnancy and Live Birth in ART

University Hospital, Bordeaux·interventional·Posted Feb 8, 2010·Updated Apr 8, 2015

In Brief

A Phase 3 clinical trial evaluating biopsy and IVF for Primary or Secondary Infertility. Completed, enrolled 190 participants across 3 sites.

Detailed Summary

In vitro fertilization (IVF) is the only available solution for many couples with various forms of infertility. The embryo implantation step in the IVF procedure is a complex multistage process and represents the majority of the causes of the IVF failure. Several approaches have been evaluated to improve implantation rates but none has demonstrated its superiority. However, endometrial receptivity is important for pregnancy and several studies suggest that local injury to the endometrium of IVF patients improves the rates of embryo implantation, clinical pregnancy and live birth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary or Secondary Infertility
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2010
Enrollment StartFeb 1, 2010
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 16.4 years ago

Interventions

biopsyprocedure

The endometrium biopsy will be done as the same time as the GnRH treatment. The biopsy is realised with a Pipette de Cornier® (CDD international, PROMIDED France) following the laboratory protocol: * Apply antiseptic solution (povidone-iodine, Dakin®) on the cervix and vagina. In most cases, using Pozzi forceps is not necessary. * Insert carefully the pipelle de Cornier® in the uterus through the cervix. * Withdraw the piston to create a negative pression * Move the pipelle de cornier® in and out while twisting. Take care to no remove the pipelle form the uterus (suction lost). Twist the pipelle de Cornier® to cover an angle of 360°. Make several "in and out" cycle in order to collect a complete sample of the endometrium. * Withdraw the pipelle de Cornier® when filled with tissue * Reinsert internal piston to deposit sample in cup filled with a fixative.

IVFprocedure

fresh IVF-embryo transfer treated with long protocol for the controlled ovarian hyperstimulation