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Infertility Markers in Serum, Urine, and Follicular Fluid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00194220
First received: September 13, 2005
Last updated: September 28, 2015
Last verified: September 2015
  Purpose

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).


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Markers in Women Undergoing Infertility Treatment

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Biospecimen Retention:   Samples With DNA
Blood, Urine, Follicular Fluid

Enrollment: 1235
Study Start Date: September 2002
Study Completion Date: February 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing In vitro fertilization at the University of Pennsylvania
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00194220

Locations
United States, Pennsylvania
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Kurt T Barnhart, MD, MSCE University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00194220     History of Changes
Other Study ID Numbers: 706658  RRU011 
Study First Received: September 13, 2005
Last Updated: September 28, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Infertility
Oxidative stress

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on December 07, 2016