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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185715
• Other study ID #: SMD-2014-121
• Status: Completed
• Phase: N/A
• First received: May 19, 2017
• Last updated: June 12, 2017
• Start date: October 2014
• Est. completion date: May 2017

Study information

• Verified date: June 2017
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Counseling
• Decision Making
• Infertility
• Infertility, Female

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

References & Publications (4)

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. — View 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. Review. — View 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. Epub 2007 May 9. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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