Transfer Strategy in an Oocyte Donation Programme

June 28, 2021 updated by: Elisabet Clua Obrado, Institut Universitari Dexeus

Pilot Study of the Best Transfer Strategy in an Oocyte Donation Programme: an Intention to Treat Randomized Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelons
      • Barcelona, Barcelons, Spain, 08028
        • Department Obstetric, Gynecologic and Reproductive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2017

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

March 18, 2017

First Submitted That Met QC Criteria

March 18, 2017

First Posted (Actual)

March 23, 2017

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMD-2017-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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