eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer

University Hospital Virgen de las Nieves

Status: Completed

Conditions: Infertility; Pregnancy, Multiple

Treatments: Procedure: Elective single embryo transfer; Procedure: Double embryo transfer

Study type: Interventional

Funder types: Other

Identifiers

NCT01909570

FIS09/1968

Details and patient eligibility

About

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

Full 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.

Enrollment: 194 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

Elective single embryo transfer

Experimental group

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

Treatment:

Procedure: Elective single embryo transfer

Double embryo transfer

Active Comparator group

Description:

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

Treatment:

Procedure: Double embryo transfer