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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female; Decision Making; Counseling
• Intervention / Treatment: Behavioral: Oral and written counselling

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Counseling policy embryo transfer; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institut Universitari Dexeus
• Investigators: Principal Investigator: Elisabet Clua, PhD, Institut Universitari Dexeus

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: oocyte donation; decision-making; recipient counselling; single embryo transfer (SET); double embryo transfer (DET)
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: SMD-2014-121

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