NCT02652143

Brief Summary

This Clinical Study has been designed to assess and compare the impact of in vitro or in vivo culture conditions on the euploidy of sibling blastocysts.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

January 7, 2016

Last Update Submit

April 3, 2019

Conditions

InfertilityReproductive Sterility

Keywords

in vivo culture

Outcome Measures

Primary Outcomes (1)

  • Euploidy status after a biopsy on all viable day 5 embryos

    full genome analysis on 24 chromosomes

    1 week

Secondary Outcomes (2)

  • Implantation rate

    9 weeks

  • Pregnancy rate

    9 weeks

Study Arms (2)

sibling oocytes in vivo

EXPERIMENTAL

randomized oocytes assigned to in vivo culture

Device: AneVivo (Medical device for in vivo culture of embryos)

sibling oocyte in vitro

ACTIVE COMPARATOR

randomized oocytes assigned to in vitro culture

Other: comparator for embryo culture in vitro

Interventions

AneVivo (Medical device for in vivo culture of embryos)DEVICE
Also known as: Anecova
sibling oocytes in vivo
comparator for embryo culture in vitroOTHER
sibling oocyte in vitro

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed Informed Consent by the subject and her partner
  • Women, aged between 18 and 38 years (up to 38th birthday)
  • ≤ 2 previous stimulation cycles
  • Routinely measured hormonal levels within normal range (i.e. FSH, LH, E2, PRL)
  • No uterine or ovarian anatomical abnormalities and/or alterations that would compromise device delivery or function in the uterus as demonstrated by ultrasound and trial insertion
  • ≤ BMI ≤ 29 kg/m2

You may not qualify if:

  • History of previous moderate or severe ovarian hyperstimulation syndrome (OHSS)
  • Severe endometriosis
  • Any active infection that would contraindicate ART, at the discretion of the investigator
  • Severe male factor in the partner (cryptozoospermia or non-obstructive azoospermia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivi Bilbao

Bilbao, Spain

Location

MeSH Terms

Conditions

Infertility

Interventions

Equipment and SuppliesIn Vitro Techniques

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Marcos Ferrando, MD

    IVI Bilbao

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 11, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations

ES(1)