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

Not Applicable

Completed

• Conditions: Decision Making; Counseling; Infertility, Female
• Interventions: Behavioral: Oral and written counselling

• Registration Number: NCT03185715
• Lead Sponsor: Institut Universitari Dexeus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Study First Submitted: 2017-05-19
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-12
• Last Update Submitted: 2017-06-12
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Counseling policy embryo transfer	Oral and written counselling	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.

Primary Outcome Measures

Name	Time	Method
Preference change on the number of embryos to be transferred	Up to 3 months	Preference was evaluated at the first consultation and after counselling using a self-report questionnaire.

Secondary Outcome Measures

Name	Time	Method
Factors which determine the initial preference on the number of embryos to be transferred	At the first consultation	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	Up to 3 months	Each factor is scored 1-10 according its relevance. Score before counselling and score after counselling were compared.