Single Embryo Transfer Versus Double Embryo Transfer

This study has been terminated.
(Change in cryopreservation protocol)
Sponsor:
Information provided by (Responsible Party):
Manuel Fernandez-Sanchez, IVI Sevilla
ClinicalTrials.gov Identifier:
NCT00814398
First received: December 23, 2008
Last updated: January 15, 2016
Last verified: March 2011
  Purpose
The aim of this project is to study the best number (1 or 2)and day (3 vs 5)of embryo transfer in good prognosis patient.

Condition Intervention
Infertility
Procedure: Double Embryo Transfer (DET)
Procedure: Single Embryo Transfer (SET)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Single Embryo Transfer Versus Double Embryo Transfer in Day 3 or Blastocyst Stage

Resource links provided by NLM:


Further study details as provided by IVI Sevilla:

Primary Outcome Measures:
  • Live-birth delivery rate [ Time Frame: End of pregnancy (nine months after last transfer) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Multiple live-birth rate [ Time Frame: End of pregnancy (nine months after last transfer) ] [ Designated as safety issue: No ]
  • Acceptance of assigned randomised group [ Time Frame: Day of randomisation ] [ Designated as safety issue: No ]

Enrollment: 199
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SET on day 3
Single embryo transfer on day 3 of embryo development
Procedure: Single Embryo Transfer (SET)
A single embryo is transferred during an IVF treatment
Experimental: DET on day 3
Double embryo transfer on day 3 of embryo development
Procedure: Double Embryo Transfer (DET)
Two embryos are transferred during an IVF treatment
Experimental: SET on day 5
Single embryo transfer on day 5 of embryo development
Procedure: Single Embryo Transfer (SET)
A single embryo is transferred during an IVF treatment
Experimental: DET on day 5
Double embryo transfer on day 5 of embryo development
Procedure: Double Embryo Transfer (DET)
Two embryos are transferred during an IVF treatment

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:G

  • Good prognosis IVF patients

Exclusion Criteria:

  • Bad prognosis IVF patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814398

Locations
Spain
IVI-Sevilla
Seville, Spain, 41011
Sponsors and Collaborators
IVI Sevilla
Investigators
Principal Investigator: Manuel Fernandez, MD IVI Sevilla
  More Information

Responsible Party: Manuel Fernandez-Sanchez, Primary Investigator, IVI Sevilla
ClinicalTrials.gov Identifier: NCT00814398     History of Changes
Other Study ID Numbers: IVISEV-002SET 
Study First Received: December 23, 2008
Last Updated: January 15, 2016
Health Authority: Spain: Ministry of Health

Keywords provided by IVI Sevilla:
Infertility
IVF
SET
DET
Blastocyst

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 28, 2016