eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer

Not Applicable

Completed

• Conditions: Infertility; Pregnancy, Multiple
• Interventions: Procedure: Elective single embryo transfer; Procedure: Double embryo transfer

• Registration Number: NCT01909570
• Lead Sponsor: University Hospital Virgen de las Nieves

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2013-07-24
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-26
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2015-02-03
• Results First Submitted QC: 2015-02-03
• Results First Posted: 2015-02-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 194

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elective single embryo transfer	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
Double embryo transfer	Double embryo transfer	After the FIV/ICSI procedure, in this arm the embryo transfer woub be of two fresh embryos

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	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

Secondary Outcome Measures

Name	Time	Method
Multiple Pregnancy Rate	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

Trial Locations

Locations (1)

Unidad de gestión clínica de ginecología y obstetricia. Instituto Biosanitario de Granada.Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain