eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer

N/ACompletedNCT01909570

University Hospital Virgen de las Nieves194 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

194

Conditions

Infertility Pregnancy, Multiple

Interventions

Elective single embryo transferPROCEDURE

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 transferPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 37 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Granada, Spain

Outcomes

Primary Outcomes

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

Time frame: Seven weeks after embryo transfer

Secondary Outcomes

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

Time frame: Seven weeks after embryo transfer

Data from ClinicalTrials.gov

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