NCT01507883

Brief Summary

Current human IVF technology employs two strategies with respective culture media for embryo development; 'let the embryo choose' (utilizes single step media) and 'back-to-nature' (utilizes sequential media). To our knowledge, there is not any sibling oocyte study to evaluate potential advantages/disadvantages of these strategies on one another.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

January 9, 2012

Last Update Submit

January 10, 2012

Conditions

Keywords

SupervisionembryosResulting

Study Arms (1)

human oocytes/embryos

Sibling oocytes cultured in single or sequential media until day6

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women who had undergone infertility treatment and oocytes subjected to ICSI

You may qualify if:

  • Cycles which have gone through egg retrieval procedure between March to November 2011 were included into the study.There was no restriction on the number of previous trials and/or sperm source.

You may not qualify if:

  • The maximum number of retrieved oocytes was restricted to 12 and the minimum to 2, as the former was the capacity of one dish (EmbryoSlide™) in which oocytes/embryos could be placed and the latter was the minimum number to be able to make a comparison between groups. Women who were older than 40 years of age were excluded in order to minimize the impact of increased risk of aneuploidy on the results.
  • Cycles in which oocytes/embryos have been subjected to biopsy were also excluded due to the potential risk of delayed embryo development in such cases (Kirkegaard et al., 2011).
  • Furthermore, cycles in which diagnosis of infertility was endometrial factor were not included since such aetiology could negatively affect implantation despite good embryo development.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahceci Fulya IVF Clinic

Istanbul, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Human embryos

Study Officials

  • Nadir H Ciray, MD., PhD

    Bahceci Health Group

    PRINCIPAL INVESTIGATOR
  • Turan Aksoy, BS

    Bahceci Health Group

    STUDY CHAIR
  • Mustafa Bahceci, MD

    Bahceci Health Group

    STUDY DIRECTOR
  • Cihan Goktas, BS

    Bahceci Health Group

    STUDY CHAIR
  • Birgen Ozturk, BS

    Bahceci Health Group

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD., PhD

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 11, 2012

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations