NCT01219439

Brief Summary

The researchers propose to investigate the causes, incidence, and time-related events of chromosomal and physiologic abnormalities as they relate to patient diagnosis, fertility drugs utilized, and in vitro laboratory culture conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

15.4 years

First QC Date

October 8, 2010

Last Update Submit

May 2, 2023

Conditions

Non-viable OocytesExtra SpermatozoaSeminal FluidGranulosa CellsSerumFollicular FluidConditioned IVF Media

Keywords

discarded pathological specimensdiscarded mediaIVF

Outcome Measures

Primary Outcomes (1)

  • Methods for the freezing of ooyctes and sperm

    To test, standardize and implement better methods for the freezing of ooyctes and sperm prior to these techniques being used in the clinical setting.

    duration of study

Secondary Outcomes (1)

  • New methods of gene and chromosome analysis

    duration of study

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing infertility treatment.

You may qualify if:

  • none

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Assoicates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA: Non-viable oocytes, spermatozoa, granulosa cells and follicular fluid Samples without DNA: seminal fluid, serum and conditioned IVF media

Study Officials

  • Richard T Scott, MD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 13, 2010

Study Start

July 1, 2007

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

May 3, 2023

Record last verified: 2023-05

Locations

US(1)