CompletedNCT01904006AGRUPADOUpdated Apr 25, 2018

Impact of Human Embryo Culture System on Live Birth

An interventional study of New Culture Condition and Standard Culture Condition in Embryo Culture, sponsored by Vida Recoletas Sevilla. Completed at 1 site in Spain. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2018-04-25.

Sponsored by Vida Recoletas Sevilla · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 182
Allocation: Randomized
Ages: 18 Years to 38 Years
Sex: Female

Study 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®).

Conditions studied

Embryo Culture

Keywords

grouped embryo culture
embryo density
low oxygen
benchtop incubator
culture condition

In context

Lead sponsor

Vida Recoletas Sevilla is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 38 Years
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

\<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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 182 participants (actual)

Study arms

Experimental
New Culture Condition
Intervention group embryos cultured grouped under low oxygen tension in benchtop incubators.
Procedure: New Culture Condition
Active comparator
Standard Culture Condition
Control group embryos cultured individually under atmospheric oxygen tension in large-box incubators.
Procedure: Standard Culture Condition

Interventions

ProcedureNew Culture Condition
Intervention group embryos cultured grouped (5 embryos per drop) under low oxygen tension (5%) in benchtop incubators.
ProcedureStandard Culture Condition
Control group embryos cultured individually (1 embryo per drop) under atmospheric oxygen tension (20%) in large-box incubators.

What researchers measure

Primary outcomes

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.
Time frame: April 2013 - October 2016

Secondary outcomes

Implantation rate
Number of embryos implanted per number of embryos transferred
Time frame: April 2013 - October 2016
Live birth rate
Number of newborns per pregnancy achieved
Time frame: April 2013 - October 2016

Other outcomes

Fecundation rate
Time frame: April 2013 - October 2016
Mean number of viable embryos
Time frame: April 2013 - October 2016
Blastocyst rate
Time frame: April 2013 - October 2016
Mean number of embryos transferred
Time frame: April 2013 - October 2016
Live Birth rate per embryos transferred
Time frame: April 2013 - October 2016
Multiple pregnancy rate
Time frame: April 2013 - October 2016
Clinical miscarriage rate
Time frame: April 2013 - October 2016

Study locations

1 site

IVI Sevilla
Seville, Seville 41011, Spain

References and documents

Publications

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. PubMed 31994003 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2013 to primary completion in Nov 2015, 27 months.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 17, 2013
First posted: Jul 19, 2013
StartActual: Jul 23, 2013
Primary completionActual: Nov 17, 2015
CompletionActual: Oct 2016
Last update: Apr 25, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01904006
Lead sponsor: Vida Recoletas Sevilla
Responsible party: Sponsor
First posted: Jul 19, 2013
Start date: Jul 23, 2013
Primary completion: Nov 17, 2015
Completion: Oct 2016
Last update: Apr 25, 2018

Study contacts

Myriam Ruiz, MSc

study chair · Vida Recoletas Sevilla

Victor Blasco, MSc

study chair · Vida Recoletas Sevilla

Manuel Fernandez-Sánchez, PhD

study director · Vida Recoletas Sevilla

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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