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

NCT ID: NCT03185715

Last Updated: 2017-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Decision Making Infertility, Female Counseling

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Oral and written counselling

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fundacion Dexeus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elisabet Clua Obrado

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elisabet Clua, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundacion Dexeus

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12571190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18565969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17490657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19442970 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SMD-2014-121

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Egg-Banking and Ovo-donation
NCT00785993 COMPLETED PHASE4
Frozen Embryo Donation Study
NCT01883934 COMPLETED NA