NCT02586324

Brief Summary

In this research, the two media used are Global medium and SSM medium with serum), which are routinely used in the reproduction biology unit. This study simply consists in setting up a methodology to compare these to media. The only constraint placed on patients is to accept randomization for the type of medium used.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2015

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

1.2 years

First QC Date

October 23, 2015

Last Update Submit

March 9, 2016

Conditions

Culture, ICSI, IVF

Outcome Measures

Primary Outcomes (1)

  • Rate of pregnancies and deliveries

    Up to 9 months

Study Arms (2)

global medium

OTHER
Biological: global medium

SSM

EXPERIMENTAL
Biological: SSM

Interventions

global mediumBIOLOGICAL
global medium
SSMBIOLOGICAL
SSM

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Any IVF and IVF with ICSI procedure performed in the unit can be included in the study

You may not qualify if:

  • refusal of patients to be randomized. In this case, the biologist chose the medium to be used and the IVF procedure will not be included in the statistical analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 26, 2015

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 10, 2016

Record last verified: 2016-03