Infertility Markers in Serum, Urine, and Follicular Fluid

September 28, 2015 updated by: University of Pennsylvania

Markers in Women Undergoing Infertility Treatment

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1235

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Reproductive Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing In vitro fertilization at the University of Pennsylvania

Description

Inclusion Criteria:

  • Women aged 18-50

  • Infertility patients only:

    1. Women undergoing infertility treatment (with or without in-vitro fertilization) at the University of Pennsylvania's PENN Fertility Care

    2. 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:

    1. Not undergoing infertility treatment
    2. Not using hormonal contraception

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 706658
  • RRU011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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