eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer (eSET)

December 17, 2021 updated by: Ana Clavero Gilabert, University Hospital Virgen de las Nieves

Randomized Clinical Trial Comparing Elective Single Embryo Transfer 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18014
        • Unidad de gestión clínica de ginecología y obstetricia. Instituto Biosanitario de Granada.Hospital Universitario Virgen de las Nieves

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elective single embryo transfer
After the FIV/ICSI procedure, in this arm the embryo transfer would be of a single embryo followed by the cryotransfer or a single embryo in case of no fresh conception
Procedure: Elective single embryo transfer
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.
Active Comparator: Double embryo transfer
After the FIV/ICSI procedure, in this arm the embryo transfer woub be of two fresh embryos
Procedure: Double embryo transfer
After the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Seven weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Seven weeks after embryo transfer

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live Birth Delivery Rate
Time Frame: 38 weeks after embryo transfer
The delivery of a healthy child (o two)
38 weeks after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Virgen de las Nieves

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Ana Clavero, PhD, Investigator and laboratory specialist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

July 24, 2013

First Posted (Estimate)

July 26, 2013

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

December 17, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS09/1968

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on Elective single embryo transfer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe