NCT00194220

Brief Summary

This study is only collecting specimens from current patients of PENN Fertility Care. The purpose of this investigation is to assess if markers of oxidative stress that are known to be associated with other medical conditions can be detected in women undergoing infertility treatment and normal women of similar age. Oxidative stress may affect a woman's eggs or the follicular cells that surround and nurture them. Other markers of to be investigated include markers of cellular aging and DNA structural changes. Presence of these markers will be compared in blood and urine samples taken during infertility treatment, and follicular fluid at the time of IVF (if applicable).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2002

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

September 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

9.8 years

First QC Date

September 13, 2005

Last Update Submit

September 28, 2015

Conditions

Infertility

Keywords

InfertilityOxidative stress

Eligibility Criteria

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

Women undergoing In vitro fertilization at the University of Pennsylvania

You may qualify if:

  • Women aged 18-50
  • Infertility patients only:
  • Women undergoing infertility treatment (with or without in-vitro fertilization) at the University of Pennsylvania's PENN Fertility Care
  • Verified infertility diagnosis of any of the following:
  • Endometriosis (minimal or mild)
  • Endometriosis (moderate or severe)
  • Tubal factor
  • Hypogonadotrophic hypogonadism
  • Polycystic ovary syndrome
  • Diminished ovarian reserve
  • Male factor
  • Unexplained
  • Healthy normal volunteers only:
  • Not undergoing infertility treatment
  • Not using hormonal contraception

You may not qualify if:

  • Currently pregnant or breastfeeding
  • Post-menopausal
  • Concurrent participation in investigational trial
  • Other health problems which, in the opinion of the investigator, may affect participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Urine, Follicular Fluid

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Kurt T Barnhart, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

September 1, 2002

Primary Completion

July 1, 2012

Study Completion

February 1, 2013

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

US(1)