Randomized Clinical Trial Comparing Elective Single Embryo Transfer Plus Single Embryo Cryotransfer vs Double Embryo Transfer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 194
- Locations
- 1
- Primary Endpoint
- Clinical Pregnancy Rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 37 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Elective single embryo transfer (Procedure)
Double embryo transfer
After the FIV/ICSI procedure, in this arm the embryo transfer woub be of two fresh embryos
Intervention: Double embryo transfer (Procedure)
Outcomes
Primary Outcomes
Clinical Pregnancy Rate
Time Frame: 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 Outcomes
- Multiple Pregnancy Rate(Seven weeks after embryo transfer)
Investigators
Ana Clavero Gilabert
PhD MD
University Hospital Virgen de las Nieves