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Completed

NCT Number: NCT01909570

eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer

The purpose of this study is to determine whether a policy of elective single embryo transfer (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms of clinical pregnancy rate

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Key information

Conditions

Infertility Genital Diseases Pregnancy, Multiple Urogenital Diseases

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Unidad de gestión clínica de ginecología y obstetricia. Instituto Biosanitario de Granada.Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

About this study

The objective is to evaluate the In Vitro Fertilization/Intracytoplasmic Sperm Inyection (IVF/ICSI) results in terms of clinical pregnancy and multiple pregnancy rates, comparing elective single embryo transfer plus cryotransfer of one embryo if pregnancy is not achieved, with double embryo transfer.

This is a prospective randomized study, including couples arriving to the Reproductive Unit of the Hospital Universitario Virgen de las Nieves. All these patients had good reproductive prognosis and had been asigned randomly to one of the following groups: Group 1: elective single embryo transfer. In the case pregnancy is not achieved a cryotransfer of one embryo will be carried out. Group 2: elective double embryo transfer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women less tan 38 years
  • women Body Mass Index (BMI) between 19-39 kg/m2
  • Follicle-Stimulating Hormone (FSH) <15 mUI/mL on cycle third day
  • First IVF/ICSI cycle or second after a positive pregnancy test in the first one

Exclusion criteria

  • More tan five years of infertility
  • Previous uterus surgery
  • Uterus malformations
  • More tan one miscarriage

Treatment and study plan

Elective single embryo transfer

Procedure

After the FIV/ICSI procedure, the embryo transfer in this arm would be of one embryo followed by the cryotransfer of one embryo in case of no conception in the fresh cycle.

Double embryo transfer

Procedure

After the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos

Primary outcomes

  1. Clinical Pregnancy Rate

    Time frame: Seven weeks after embryo transfer

    A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy

Secondary outcomes

  1. Multiple Pregnancy Rate

    Time frame: Seven weeks after embryo transfer

    A multiple clinical pregnancy was defined by the presence of more than one gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy

Other outcomes

  1. Live Birth Delivery Rate

    Time frame: 38 weeks after embryo transfer

    The delivery of a healthy child (o two)

Sponsors and collaborators

Lead sponsor

University Hospital Virgen de las Nieves

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

Randomized Clinical Trial Comparing Elective Single Embryo Transfer Plus Single Embryo Cryotransfer vs Double Embryo Transfer

Acronym: eSET

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 26, 2013
Registry last updated
May 16, 2024

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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