NCT01223092

Brief Summary

The purpose of this this study is to use DNA screening strategies to identify genes and localize genomic regions that are differentially expressed in patients with infertility to further understand the genetic basis for reproductive competence.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress98%
Feb 2006Dec 2026

Study Start

First participant enrolled

February 1, 2006

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 18, 2010

Completed
15.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

19.8 years

First QC Date

October 8, 2010

Last Update Submit

February 4, 2025

Conditions

Infertility

Keywords

IVFinfertilityDNA

Outcome Measures

Primary Outcomes (1)

  • Number of retrieved oocytes

    1 month

Secondary Outcomes (3)

  • Fertilization rate

    1 month

  • Number of available embryos

    1 month

  • Pregnancy rates

    1 year

Study Arms (1)

Patients undegoing infertility treatment

Male and female patients undergoing infertility treatment

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing infertility treamtnet

You may qualify if:

  • all patients undergoing fertility care

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Related Publications (2)

  • Patounakis G, Treff N, Tao X, Lonczak A, Scott RT Jr, Frattarelli JL. The p53 codon 72 single nucleotide polymorphism lacks a significant effect on implantation rate in fresh in vitro fertilization cycles: an analysis of 1,056 patients. Fertil Steril. 2009 Oct;92(4):1290-1296. doi: 10.1016/j.fertnstert.2008.07.1783. Epub 2008 Oct 17.

    PMID: 18930193BACKGROUND

  • Patounakis G, Bergh E, Forman EJ, Tao X, Lonczak A, Franasiak JM, Treff N, Scott RT Jr. Multiple thrombophilic single nucleotide polymorphisms lack a significant effect on outcomes in fresh IVF cycles: an analysis of 1717 patients. J Assist Reprod Genet. 2016 Jan;33(1):67-73. doi: 10.1007/s10815-015-0606-z. Epub 2015 Nov 6.

    PMID: 26545911DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood serum, follicular fluid and sperm

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Jason Franasiak, MD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 18, 2010

Study Start

February 1, 2006

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

February 7, 2025

Record last verified: 2025-02

Locations

US(1)