NCT01904006

Brief Summary

Previous studies in human and different mammals have proved that the embryo group culture (in the same culture medium drop) using a reduced volume is associated with a better embryo development. This is due to the effect of different autocrine and paracrine factors secreted by the embryos. Besides, previous studies with embryos from human and other mammals have shown that a high oxygen concentration may have a negative effect on embryo quality due to the generation of reactive oxygen species, which cause oxidative stress. The embryo culture at low oxygen tension is correlated to better success rates in IVF/ICSI treatments. The purpose of this study is to evaluate the combined effect of the embryo group culture and the low oxygen tension on the embryo development and the results of the IVF/ICSI treatments. The specific goal is to compare the embryo group culture in a reduced volume of medium at a low oxygen tension (5%) with the standard individual culture at an atmospheric oxygen tension (20%). The first culture condition will be applied in a K-MINC incubator (COOK Medical®), whereas the second condition will be applied using a Heracell incubator (Heraeus®).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration 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

First Submitted

Initial submission to the registry

July 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

July 23, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

July 17, 2013

Last Update Submit

April 24, 2018

Conditions

Embryo Culture

Keywords

grouped embryo cultureembryo densitylow oxygenbenchtop incubatorculture condition

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Confirmed when a gestational sac with heartbeat was observed in the uterus by ultrasound examination, performed 2-3 weeks after the positive result of the beta-hCG pregnancy test.

    April 2013 - October 2016

Secondary Outcomes (2)

  • Implantation rate

    April 2013 - October 2016

  • Live birth rate

    April 2013 - October 2016

Other Outcomes (7)

  • Fecundation rate

    April 2013 - October 2016

  • Mean number of viable embryos

    April 2013 - October 2016

  • Blastocyst rate

    April 2013 - October 2016

  • +4 more other outcomes

Study Arms (2)

New Culture Condition

EXPERIMENTAL

Intervention group embryos cultured grouped under low oxygen tension in benchtop incubators.

Procedure: New Culture Condition

Standard Culture Condition

ACTIVE COMPARATOR

Control group embryos cultured individually under atmospheric oxygen tension in large-box incubators.

Procedure: Standard Culture Condition

Interventions

New Culture ConditionPROCEDURE

Intervention group embryos cultured grouped (5 embryos per drop) under low oxygen tension (5%) in benchtop incubators.

New Culture Condition
Standard Culture ConditionPROCEDURE

Control group embryos cultured individually (1 embryo per drop) under atmospheric oxygen tension (20%) in large-box incubators.

Standard Culture Condition

Eligibility Criteria

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

You may qualify if:

  • \<38 years (with own oocytes) / \<45 years (with oocyte donation).
  • First treatment with own oocytes / any treatment with oocyte donation.
  • ≥10 oocytes with a diameter of ≥10 mm.

You may not qualify if:

  • Diseases that affect endometrial receptivity: endometriosis, hydrosalpinx, ovarian hyperstimulation syndrome, obesity, endocrinopathies, thrombophilia, congenital or acquired uterine anomalies.
  • Patients under a treatment with genetic preimplantation diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Sevilla

Seville, Seville, 41011, Spain

Location

Related Publications (1)

  • Ruiz M, Santamaria-Lopez E, Blasco V, Hernaez MJ, Caligara C, Pellicer A, Fernandez-Sanchez M, Prados N. Effect of Group Embryo Culture under Low-Oxygen Tension in Benchtop Incubators on Human Embryo Culture: Prospective, Randomized, Controlled Trial. Reprod Sci. 2020 Jul;27(7):1522-1533. doi: 10.1007/s43032-020-00150-5. Epub 2020 Jan 28.

    PMID: 31994003DERIVED

Study Officials

  • Myriam Ruiz, MSc

    Vida Recoletas Sevilla

    STUDY CHAIR

  • Victor Blasco, MSc

    Vida Recoletas Sevilla

    STUDY CHAIR

  • Manuel Fernandez-Sánchez, PhD

    Vida Recoletas Sevilla

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 19, 2013

Study Start

July 23, 2013

Primary Completion

November 17, 2015

Study Completion

October 1, 2016

Last Updated

April 25, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)