Clinical trial NCT01904006: Impact of Human Embryo Culture System on Live Birth
Official title: Improvement of Live Birth Rate With a New Standardized Human Embryo Culture System: a Prospective, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo Culture
Keywords: grouped embryo culture
embryo density
low oxygen
benchtop incubator
culture condition
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
First posted: 2013-07-19
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®).


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: April 2013 - October 2016
Secondary outcomes:
measure: Implantation rate
timeFrame: April 2013 - October 2016
measure: Live birth rate
timeFrame: April 2013 - October 2016
Other outcomes:
measure: Fecundation rate
timeFrame: April 2013 - October 2016
measure: Mean number of viable embryos
timeFrame: April 2013 - October 2016
measure: Blastocyst rate
timeFrame: April 2013 - October 2016
measure: Mean number of embryos transferred
timeFrame: April 2013 - October 2016
measure: Live Birth rate per embryos transferred
timeFrame: April 2013 - October 2016
measure: Multiple pregnancy rate
timeFrame: April 2013 - October 2016
measure: Clinical miscarriage rate
timeFrame: April 2013 - October 2016
Locations:
city: Sevilla
country: Spain
facility: IVI Sevilla
state: Seville
Study officials:
affiliation: Vida Recoletas Sevilla
name: Myriam Ruiz, MSc
role: STUDY_CHAIR
affiliation: Vida Recoletas Sevilla
name: Victor Blasco, MSc
role: STUDY_CHAIR
affiliation: Vida Recoletas Sevilla
name: Manuel Fernandez-Sánchez, PhD
role: STUDY_DIRECTOR
References:
citation: 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.