Impact of Human Embryo Culture System on Live Birth

Embryo Culture Clinical Trial

— AGRUPADO  

Official title:

Improvement of Live Birth Rate With a New Standardized Human Embryo Culture System: a Prospective, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904006
• Other study ID #: IVISEV-003AGR
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: April 24, 2018
• Start date: July 23, 2013
• Est. completion date: October 2016

Study information

• Verified date: April 2018
• Source: IVI Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: October 2016
• Est. primary completion date: November 17, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embryo Culture

Intervention

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

Locations

Country	Name	City	State
Spain	IVI Sevilla	Sevilla	Seville

Sponsors (1)

Lead Sponsor	Collaborator
IVI Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fecundation rate		April 2013 - October 2016
Other	Mean number of viable embryos		April 2013 - October 2016
Other	Blastocyst rate		April 2013 - October 2016
Other	Mean number of embryos transferred		April 2013 - October 2016
Other	Live Birth rate per embryos transferred		April 2013 - October 2016
Other	Multiple pregnancy rate		April 2013 - October 2016
Other	Clinical miscarriage rate		April 2013 - October 2016
Primary	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	Implantation rate	Number of embryos implanted per number of embryos transferred	April 2013 - October 2016
Secondary	Live birth rate	Number of newborns per pregnancy achieved	April 2013 - October 2016