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Oocyte Recipient's Decision in the Number of Embryos to be Transferred

Primary Purpose

Decision Making, Infertility, Female, Counseling

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Oral and written counselling
Sponsored by
Institut Universitari Dexeus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Decision Making focused on measuring oocyte donation, recipient counselling, single embryo transfer (SET), double embryo transfer (DET), decision-making

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients under their first oocyte or embryo donation cycle.
  • Sufficient knowledge of Spanish to fill out questionnaires.

Exclusion Criteria:

  • Patients with a medical indication for single embryo transfer (e.g. Turner syndrome, uterine surgeries, cardiovascular risk).
  • Having had previous oocyte or embryo donation cycles.
  • Insufficient knowledge of Spanish.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Counseling policy embryo transfer

    Arm Description

    All recipients completed a validated self-report questionnaire on the preference on the number of embryos to be transferred and the relevance for the decision-making process attributed to certain factors. The questionnaire also included questions on sociodemographic characteristics, medical-reproductive background and cycle's results and risks perception. All recipients received oral and written counselling. After counselling, during the treatment, the recipients completed a second questionnaire in order to check if their decision had changed.

    Outcomes

    Primary Outcome Measures

    Preference change on the number of embryos to be transferred
    Preference was evaluated at the first consultation and after counselling using a self-report questionnaire.

    Secondary Outcome Measures

    Factors which determine the initial preference on the number of embryos to be transferred
    Factor's weight is analysed using a self-report questionnaire. Each factor is scored 1-10 according its relevance.
    Factors which can explain a change in the preference on the number of embryos to be transferred
    Each factor is scored 1-10 according its relevance. Score before counselling and score after counselling were compared.

    Full Information

    First Posted
    May 19, 2017
    Last Updated
    June 12, 2017
    Sponsor
    Institut Universitari Dexeus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03185715
    Brief Title
    Oocyte Recipient's Decision in the Number of Embryos to be Transferred
    Official Title
    Single or Double Embryo Transfer? Decision-making Process in Patients Participating in an Oocyte Donation Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Institut Universitari Dexeus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Multiple pregnancies are considered an ART complication. The only effective way to reduce its incidence is to transfer a single embryo. Nonetheless, there is some reluctance among the patients to accept this strategy. In IVF/ICSI programs, it has been demonstrated that, after receiving the information about the similar cumulative live birth rate after single embryo transfer (SET) and double embryo transfer (DET) and the obstetric and perinatal risks of multiple pregnancy, a significant number of patients opt for SET. Up to date, no comparable studies have been published in oocyte recipients. The aim of this study is to evaluate if the information given to the patients influence their preference on the number of embryos to be transferred. It also seeks to identify factors which determine the initial preference and factors which can explain a hypothetic change in this preference.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Decision Making, Infertility, Female, Counseling
    Keywords
    oocyte donation, recipient counselling, single embryo transfer (SET), double embryo transfer (DET), decision-making

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Counseling policy embryo transfer
    Arm Type
    Other
    Arm Description
    All recipients completed a validated self-report questionnaire on the preference on the number of embryos to be transferred and the relevance for the decision-making process attributed to certain factors. The questionnaire also included questions on sociodemographic characteristics, medical-reproductive background and cycle's results and risks perception. All recipients received oral and written counselling. After counselling, during the treatment, the recipients completed a second questionnaire in order to check if their decision had changed.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Oral and written counselling
    Intervention Description
    Recipients were informed about success rates of SET and DET and also about the possible risks of DET. All the information was given orally and written.
    Primary Outcome Measure Information:
    Title
    Preference change on the number of embryos to be transferred
    Description
    Preference was evaluated at the first consultation and after counselling using a self-report questionnaire.
    Time Frame
    Up to 3 months
    Secondary Outcome Measure Information:
    Title
    Factors which determine the initial preference on the number of embryos to be transferred
    Description
    Factor's weight is analysed using a self-report questionnaire. Each factor is scored 1-10 according its relevance.
    Time Frame
    At the first consultation
    Title
    Factors which can explain a change in the preference on the number of embryos to be transferred
    Description
    Each factor is scored 1-10 according its relevance. Score before counselling and score after counselling were compared.
    Time Frame
    Up to 3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients under their first oocyte or embryo donation cycle. Sufficient knowledge of Spanish to fill out questionnaires. Exclusion Criteria: Patients with a medical indication for single embryo transfer (e.g. Turner syndrome, uterine surgeries, cardiovascular risk). Having had previous oocyte or embryo donation cycles. Insufficient knowledge of Spanish.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elisabet Clua, PhD
    Organizational Affiliation
    Institut Universitari Dexeus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    12571190
    Citation
    Land JA, Evers JL. Risks and complications in assisted reproduction techniques: Report of an ESHRE consensus meeting. Hum Reprod. 2003 Feb;18(2):455-7. doi: 10.1093/humrep/deg081.
    Results Reference
    background
    PubMed Identifier
    18565969
    Citation
    van Peperstraten AM, Nelen WL, Hermens RP, Jansen L, Scheenjes E, Braat DD, Grol RP, Kremer JA. Why don't we perform elective single embryo transfer? A qualitative study among IVF patients and professionals. Hum Reprod. 2008 Sep;23(9):2036-42. doi: 10.1093/humrep/den156. Epub 2008 Jun 18.
    Results Reference
    background
    PubMed Identifier
    17490657
    Citation
    Ryan GL, Sparks AE, Sipe CS, Syrop CH, Dokras A, Van Voorhis BJ. A mandatory single blastocyst transfer policy with educational campaign in a United States IVF program reduces multiple gestation rates without sacrificing pregnancy rates. Fertil Steril. 2007 Aug;88(2):354-60. doi: 10.1016/j.fertnstert.2007.03.001. Epub 2007 May 9.
    Results Reference
    background
    PubMed Identifier
    19442970
    Citation
    Hope N, Rombauts L. Can an educational DVD improve the acceptability of elective single embryo transfer? A randomized controlled study. Fertil Steril. 2010 Jul;94(2):489-95. doi: 10.1016/j.fertnstert.2009.03.080. Epub 2009 May 13.
    Results Reference
    background

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    Oocyte Recipient's Decision in the Number of Embryos to be Transferred

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