Comparison of Single vs Group Embryo Culture in Micro-well Group Culture Dish

Sponsor

Elif Güler Ergin (Other)

Overall Status

Unknown status

CT.gov ID

NCT02050516

Collaborator

Vitrolife (Industry)

160

Enrollment

Location

Arms

Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Does group culture using micro-well group culture dishes improve human blastocyst development compared to single embryo culture?

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: micro-well group culture dish	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Official Title:

Randomized Controlled Comparison of Single Embryo Culture Versus Group Culture Using a Micro-well Group Culture Dish in Humans

Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: single embryo culture single embryo culture in single drops inside micro-well group culture dish	Other: micro-well group culture dish an embryo culture dish containing nine micro-wells in the middle.
Experimental: group embryo culture group embryo culture in a single drop inside micro-well group culture dish	Other: micro-well group culture dish an embryo culture dish containing nine micro-wells in the middle.

Arm

Intervention/Treatment

Active Comparator: single embryo culture

single embryo culture in single drops inside micro-well group culture dish

Other: micro-well group culture dish

an embryo culture dish containing nine micro-wells in the middle.

Experimental: group embryo culture

group embryo culture in a single drop inside micro-well group culture dish

Other: micro-well group culture dish

an embryo culture dish containing nine micro-wells in the middle.

Outcome Measures

Primary Outcome Measures

Blastocyst development [6 days]

Secondary Outcome Measures

Implantation rate [1 month]

Other Outcome Measures

Clinical pregnancy rate [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: female age uner 40, male age under 60 patients undergoing IVF-treatment with oocyte collection after ovarian hyperstimulation having signed the study-specific consent form patient fulfilling clinic's standard criteria for blastocyst culture minimum 5 normally fertilized oocytes at the time of fertilization check

Exclusion Criteria: use of any type of surgically retrieved sperm cells patients undergoing any kind of genetic diagnosis at any developmental stage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurofertil IVF Health Center	Istanbul		Turkey

Sponsors and Collaborators

Elif Güler Ergin
Vitrolife

Investigators

Principal Investigator: Elif Güler Ergin, MD, Eurofertil IVF Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elif Güler Ergin, MD, Eurofertil IVF Health Center

ClinicalTrials.gov Identifier:

NCT02050516

Other Study ID Numbers:

WOW-1

First Posted:

Jan 30, 2014

Last Update Posted:

Jan 31, 2014

Last Verified:

Jan 1, 2014

Keywords provided by Elif Güler Ergin, MD, Eurofertil IVF Health Center

Blastocyst, micro-well group culture dish

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Jan 31, 2014