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Transfer Strategy in an Oocyte Donation Programme

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: NCT03088735
Recruitment Status : Terminated (Due to the clinically and statistically significant inferior results for the D3 group following evaluation by the institutional review board.)
First Posted : March 23, 2017
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Elisabet Clua Obrado, Institut Universitari Dexeus

Brief Summary:
It has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (D2), it is expressed on day 3 (D3). Without this activation, the embryo can not continue its development. Therefore, it has been suggested that extended culture to blastocyst stage could be an option to identify and better select embryos that have been able to carry out this activation. The purpose of this study is to compare cumulative pregnancy and live birth rates following transfer of cleavage embryos or blastocysts.

Condition or disease Intervention/treatment Phase
Oocyte Donation Infertility, Female Embryo Transfer Procedure: Blastocyst-stage embryo transfer strategy Procedure: Cleavage-stage embryo transfer strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study of the Best Transfer Strategy in an Oocyte Donation Programme: an Intention to Treat Randomized Controlled Trial
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : August 31, 2019

Arm Intervention/treatment
Experimental: Blastocyst-stage embryo transfer strategy Procedure: Blastocyst-stage embryo transfer strategy
Intra-uterine transfer of blastocist if in cleavage embryo stage the oocyte recipient has a mínimum of 3 availables embryos with at least one of good quality to transfer and also the inta-uterine transfer of cleavage embryo (day 3) when the recipient doesn't have the previous criteria.

Active Comparator: Cleavage-stage embryo transfer strategy Procedure: Cleavage-stage embryo transfer strategy
Inta-uterine transferring of cleavage embryo transfer (day 3 of develpment) in oocyte recipients




Primary Outcome Measures :
  1. Cumulative live birth rate [ Time Frame: at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle ]
    Total number of births considering fresh and frozen thawed embryos transferred


Secondary Outcome Measures :
  1. Cumulative pregnancy rate [ Time Frame: at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle ]
    Total number of pregnancies confirmed by ultrasound 6 weeks after embryo transfer including fresh and thawed embryos.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle.

Exclusion Criteria:

  • Preimplantation genetic screening or diagnosis cycles.
  • Patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician.

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): NCT03088735


Locations
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Spain
Department Obstetric, Gynecologic and Reproductive Medicine
Barcelona, Barcelons, Spain, 08028
Sponsors and Collaborators
Institut Universitari Dexeus
Additional Information:
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Responsible Party: Elisabet Clua Obrado, Head of Gamete and Embryo Donation, Institut Universitari Dexeus
ClinicalTrials.gov Identifier: NCT03088735    
Other Study ID Numbers: SMD-2017-03
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
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
Additional relevant MeSH terms:
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Infertility
Infertility, Female