Infertility Markers in Serum, Urine, and Follicular Fluid

Completed

• Conditions: Infertility

• Registration Number: NCT00194220
• Lead Sponsor: University of Pennsylvania

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2012-07
• Study Completion: 2013-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1235

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University of Pennsylvania Reproductive Research Unit; 🇺🇸 Philadelphia, Pennsylvania, United States