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OpenTrials
Completed

NCT Number: NCT03185715

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

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.

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Key information

Conditions

Decision Making Counseling Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Preference change on the number of embryos to be transferred

    Time frame: Up to 3 months

    Preference was evaluated at the first consultation and after counselling using a self-report questionnaire.

Secondary outcomes

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

    Time frame: At the first consultation

    Factor's weight is analysed using a self-report questionnaire. Each factor is scored 1-10 according its relevance.

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

    Time frame: Up to 3 months

    Each factor is scored 1-10 according its relevance. Score before counselling and score after counselling were compared.

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 14, 2017
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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