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

NCT03185715 | Completed

• 1 other identifier: SMD-2014-121
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Decision Making; Infertility, Female; Counseling

Keywords

oocyte donation; recipient counselling; single embryo transfer (SET); double embryo transfer (DET); decision-making

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Factors which determine the initial preference on the number of embryos to be transferred

  At the first consultation

• Factors which can explain a change in the preference on the number of embryos to be transferred

  Up to 3 months

Study Arms (1)

Counseling policy embryo transfer

OTHER

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

Interventions

Oral and written counselling BEHAVIORAL

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.

Counseling policy embryo transfer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Dexeus: lead

Related Publications (4)

• 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.

  PMID: 12571190 BACKGROUND

• 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.

  PMID: 18565969 BACKGROUND

• 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.

  PMID: 17490657 BACKGROUND

• 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.

  PMID: 19442970 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Elisabet Clua, PhD

  Fundacion Dexeus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: June 14, 2017
• Study Start: October 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share