Clinical trial NCT03185715: 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
Overall status: COMPLETED
Phase: NA
Conditions: Decision Making
Infertility, Female
Counseling
Keywords: oocyte donation
recipient counselling
single embryo transfer (SET)
double embryo transfer (DET)
decision-making
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Preference change on the number of embryos to be transferred
timeFrame: Up to 3 months
Secondary outcomes:
measure: Factors which determine the initial preference on the number of embryos to be transferred
timeFrame: At the first consultation
measure: Factors which can explain a change in the preference on the number of embryos to be transferred
timeFrame: Up to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Fundacion Dexeus
name: Elisabet Clua, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.