NCT01397487

Brief Summary

The aim of this study to evaluate the effect of embryo biopsy on blastocyst development and implantation rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jul 2011

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 28, 2011

Status Verified

July 1, 2011

Enrollment Period

6 months

First QC Date

July 18, 2011

Last Update Submit

July 27, 2011

Conditions

Blastomere Biopsy Safety

Keywords

morphometric parameters, embryo biopsy

Outcome Measures

Primary Outcomes (1)

  • Blastocyst percentage

    after 120 hours of culture

Secondary Outcomes (2)

  • Number of cells of blastocyst measured by morphometric analysis

    after 120 hours of culture

  • Implantation rate

    after one month of embryo transfer.

Study Arms (1)

one single arm

OTHER

All patients are included to complete a biopsy of half part of the embryos

Procedure: Blastomere biopsy

Interventions

Blastomere biopsyPROCEDURE

The blastomere biopsy will be done after 72 hours of embryo culture. An inverted microscope Olympus IX70 with a heated stage will be used to perform the biopsy. The micromanipulation for the blastomere extraction will be made with a micropipette MBB-FP-M-30 (Humagen).

one single arm

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • No relevant medical history.
  • BMI \< 25.
  • Age \< 35 years old.
  • Unexplained infertility, tubal or male cause of infertility.
  • Between 6 and 8 embryos on day 3 of embryo culture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

La Fe University Hospital. Department of Obstetrics and Gynecology

Valencia, Valencia, 46026, Spain

RECRUITING

Study Officials

  • Antonio Pellicer, MDPhD

    La Fe Hospital. Dept. of Obstetrics and Gynecology.

    STUDY DIRECTOR

  • Amparo Mercader, P.h.D

    Instituto Valenciano de Infertilidad. PGD Laboratory.

    STUDY CHAIR

Central Study Contacts

Inmaculada Molina Botella, P.h.D

CONTACT

0034 961244660mamobo1@dca.upv.es

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 19, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

September 1, 2013

Last Updated

July 28, 2011

Record last verified: 2011-07

Locations

ES(1)