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

Primary Purpose

Infertility, Pregnancy, Multiple

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Elective single embryo transfer
Double embryo transfer
Sponsored by
University Hospital Virgen de las Nieves
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elective single embryo transfer

Double embryo transfer

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Multiple Pregnancy Rate
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

Full Information

First Posted
July 24, 2013
Last Updated
December 17, 2021
Sponsor
University Hospital Virgen de las Nieves
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT01909570
Brief Title
eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer
Acronym
eSET
Official Title
Randomized Clinical Trial Comparing Elective Single Embryo Transfer Plus Single Embryo Cryotransfer vs Double Embryo Transfer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Virgen de las Nieves
Collaborators
Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Pregnancy, Multiple

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elective single embryo transfer
Arm Type
Experimental
Arm Description
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
Arm Title
Double embryo transfer
Arm Type
Active Comparator
Arm Description
After the FIV/ICSI procedure, in this arm the embryo transfer woub be of two fresh embryos
Intervention Type
Procedure
Intervention Name(s)
Elective single embryo transfer
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Double embryo transfer
Intervention Description
After the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos
Primary Outcome Measure Information:
Title
Clinical Pregnancy Rate
Description
A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy
Time Frame
Seven weeks after embryo transfer
Secondary Outcome Measure Information:
Title
Multiple Pregnancy Rate
Description
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
Time Frame
Seven weeks after embryo transfer
Other Pre-specified Outcome Measures:
Title
Live Birth Delivery Rate
Description
The delivery of a healthy child (o two)
Time Frame
38 weeks after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Clavero, PhD
Organizational Affiliation
Investigator and laboratory specialist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidad de gestión clínica de ginecología y obstetricia. Instituto Biosanitario de Granada.Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24798072
Citation
Lopez-Regalado ML, Clavero A, Gonzalvo MC, Serrano M, Martinez L, Mozas J, Rodriguez-Serrano F, Fontes J, Castilla JA. Randomised clinical trial comparing elective single-embryo transfer followed by single-embryo cryotransfer versus double embryo transfer. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:192-8. doi: 10.1016/j.ejogrb.2014.04.009. Epub 2014 Apr 19.
Results Reference
derived

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eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer

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