eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Infertility Pregnancy, Multiple

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Elective single embryo transfer

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Double embryo transfer

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Double embryo transfer

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

Intervention Type PROCEDURE

Eligibility Criteria

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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