Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Randomized Study to Evaluate the Effect of Embryonic Observation on the Gestation (PROdE) (PROdE)

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: NCT02372279
Recruitment Status : Unknown
Verified February 2016 by Jorge Ten Morro, Instituto Bernabeu.
Recruitment status was:  Recruiting
First Posted : February 26, 2015
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
Jorge Ten Morro, Instituto Bernabeu

Brief Summary:
In a conventional in vitro fertilization (IVF) cycle, daily microscopic observation of embryos outside the incubator to assess their morphology and establish a selection process is performed. In this way it is possible to know which embryo or embryos have greater implantantion capacity and will be transferred to the uterus to obtain a viable pregnancy. However, these observations can produce deleterious effects on embryo development due to changes in temperature, pH and osmolarity of the culture media, as well as a negative effect of direct light microscope for observation. This project aims to test the hypothesis that non-embryonic observation produces a beneficial effect on embryo quality until day 5 of development (blastocyst stage) and, therefore, on rates of implantation and ongoing gestation, compared with the conventional protocol of observations under the inverted microscope on days two, three and five of development.

Condition or disease Intervention/treatment Phase
Placenta; Implantation Other: Embryo observation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Official Title: Prospective Randomized Study to Evaluate the Effect of Embryonic Observation on the Implantation Rates and Ongoing Gestation
Study Start Date : February 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
No Intervention: No embryo observation (NEO)
Study group. No embryonic observation from day one to day five of embryo development.
Experimental: Embryo observation (EO)
Control group. Conventional embryonic observations performed in day two, three and five of embryo development.
Other: Embryo observation
In EO group, conventional observations will be made.




Primary Outcome Measures :
  1. Ongoing pregnancy [ Time Frame: Ongoing pregnancy until 28th week of gestation ]
    Rate of ongoing gestation considered a positive pregnancy to display normal heartbeat and ultrasound markers until the 28th week of gestation


Secondary Outcome Measures :
  1. Ongoing implantation [ Time Frame: 12th week of gestation ]
    number of implanted embryos with heartbeat presence divided by the total number of embryos transferred, multiplied by 100.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First IVF treatment using anonymous oocyte donation.
  • Normal uterine cavity assessed by ultrasound.

Exclusion Criteria:

  • More than 50 years in the moment of embryo transfer.
  • Repeated miscarriage, considered as at least two previous miscarriages.
  • Repeated implantation failure (no pregnancy with the transfer of at least 4 good quality embryos (types A and / or B) in previous cycles).

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): NCT02372279


Contacts
Layout table for location contacts
Contact: Jorge Ten Morro, Ph.D. +34696914882 jten@institutobernabeu.com

Locations
Layout table for location information
Spain
Instituto Bernabeu Recruiting
Alicante, Spain, 03016
Contact: Jorge Ten, Ph.D.    +34696914882    jten@institutobernabeu.com   
Principal Investigator: Jorge Ten Morro, Ph.D.         
Sub-Investigator: Rafael Bernabeu Pérez, M.D., Ph.D.         
Sub-Investigator: Adoración Rodríguez-Arnedo, Ph.D         
Sub-Investigator: Jaime Guerrero Villena, B. Sc.         
Sponsors and Collaborators
Instituto Bernabeu
Investigators
Layout table for investigator information
Principal Investigator: Jorge Ten Morro, Ph.D. Instituto Bernabeu
Publications:

Layout table for additonal information
Responsible Party: Jorge Ten Morro, Ph.D. Embryologist, Instituto Bernabeu
ClinicalTrials.gov Identifier: NCT02372279    
Other Study ID Numbers: InstitutoBernabeu
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016
Keywords provided by Jorge Ten Morro, Instituto Bernabeu:
Embryo development
Implantation
In vitro fertilization