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Infertility Markers in Serum, Urine, and Follicular Fluid

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ClinicalTrials.gov Identifier: NCT00194220
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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).


Condition or disease
Infertility

Study Design

Study Type : Observational
Actual Enrollment : 1235 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Markers in Women Undergoing Infertility Treatment
Study Start Date : September 2002
Primary Completion Date : July 2012
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015

Keywords provided by University of Pennsylvania:
Infertility
Oxidative stress

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