Infertility Markers in Serum, Urine, and Follicular Fluid

NCT ID: NCT00194220

Last Updated: 2015-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-09-30

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kurt T Barnhart, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Reproductive Research Unit

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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RRU011

Identifier Type: -

Identifier Source: secondary_id

706658

Identifier Type: -

Identifier Source: org_study_id

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