Impact of Human Embryo Culture System on Live Birth

Not Applicable

Completed

• Conditions: Embryo Culture
• Interventions: Procedure: Standard Culture Condition; Procedure: New Culture Condition

• Registration Number: NCT01904006
• Lead Sponsor: IVI Sevilla

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®).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-19
• Study Start: 2013-07-23
• Primary Completion: 2015-11-17
• Study Completion: 2016-10
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-24
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Culture Condition	Standard Culture Condition	Control group embryos cultured individually under atmospheric oxygen tension in large-box incubators.
New Culture Condition	New Culture Condition	Intervention group embryos cultured grouped under low oxygen tension in benchtop incubators.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	April 2013 - October 2016	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IVI Sevilla; 🇪🇸 Sevilla, Seville, Spain