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Impact of Human Embryo Culture System on Live Birth (AGRUPADO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01904006
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
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®).


Condition or disease Intervention/treatment Phase
Embryo Culture Procedure: New Culture Condition Procedure: Standard Culture Condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improvement of Live Birth Rate With a New Standardized Human Embryo Culture System: a Prospective, Randomized, Controlled Trial
Actual Study Start Date : July 23, 2013
Actual Primary Completion Date : November 17, 2015
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: New Culture Condition
Intervention group embryos cultured grouped under low oxygen tension in benchtop incubators.
Procedure: New Culture Condition
Intervention group embryos cultured grouped (5 embryos per drop) under low oxygen tension (5%) in benchtop incubators.

Active Comparator: Standard Culture Condition
Control group embryos cultured individually under atmospheric oxygen tension in large-box incubators.
Procedure: Standard Culture Condition
Control group embryos cultured individually (1 embryo per drop) under atmospheric oxygen tension (20%) in large-box incubators.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904006


Locations
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Spain
IVI Sevilla
Sevilla, Seville, Spain, 41011
Sponsors and Collaborators
IVI Sevilla
Investigators
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Study Chair: Myriam Ruiz, MSc IVI Sevilla
Study Chair: Victor Blasco, MSc IVI Sevilla
Study Director: Manuel Fernandez-Sánchez, PhD IVI Sevilla
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IVI Sevilla
ClinicalTrials.gov Identifier: NCT01904006    
Other Study ID Numbers: IVISEV-003AGR
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IVI Sevilla:
grouped embryo culture
embryo density
low oxygen
benchtop incubator
culture condition