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Completed

NCT Number: NCT01904006

Impact of Human Embryo Culture System on Live Birth

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®).

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Key information

Conditions

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVI Sevilla

Seville, 41011, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

New Culture Condition

Procedure

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

Standard Culture Condition

Procedure

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

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 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 outcomes

  1. Implantation rate

    Time frame: April 2013 - October 2016

    Number of embryos implanted per number of embryos transferred

  2. Live birth rate

    Time frame: April 2013 - October 2016

    Number of newborns per pregnancy achieved

Other outcomes

  1. Fecundation rate

    Time frame: April 2013 - October 2016

  2. Mean number of viable embryos

    Time frame: April 2013 - October 2016

  3. Blastocyst rate

    Time frame: April 2013 - October 2016

  4. Mean number of embryos transferred

    Time frame: April 2013 - October 2016

  5. Live Birth rate per embryos transferred

    Time frame: April 2013 - October 2016

  6. Multiple pregnancy rate

    Time frame: April 2013 - October 2016

  7. Clinical miscarriage rate

    Time frame: April 2013 - October 2016

Sponsors and collaborators

Lead sponsor

Vida Recoletas Sevilla

Other

Registry information

Official study title

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

Acronym: AGRUPADO

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 19, 2013
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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