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

Study Overview
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Brief Summary
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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.

Official Title
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Single or Double Embryo Transfer? Decision-making Process in Patients Participating in an Oocyte Donation Program

Conditions
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Decision Making, Counseling, Infertility, Female

Intervention / Treatment
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* Behavioral: Oral and written counselling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Counseling policy embryo transfer<br>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. | Behavioral: Oral and written counselling<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the first consultation | 
| 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. | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oocyte donation, recipient counselling, single embryo transfer (SET), double embryo transfer (DET), decision-making