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Assessing Urinary Hormones in Female Cancer Survivors

NCT ID: NCT03197532

Last Updated: 2020-11-20

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

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-05-31

Brief Summary

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Women of late to mid reproductive age may participate in a study using novel methodology to identify subtle changes in the reproductive endocrine axis via daily urine hormone analysis, which may have important implications for reproduction and may signal reproductive senescence.

Detailed Description

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Women with a reduced follicular pool either from natural aging or previous chemotherapy, may not have any clinical signs or symptoms and traditional measures of ovarian reserve, such as basal Follicle Stimulating Hormone may be within the normal range. However, there may be alterations in the luteal or follicular phases(shortened follicular phase and luteal insufficiency) due to compromised follicle competency and alterations in the H-P-O axis. Therefore this aim uses novel methodology to identify subtle changes in the reproductive endocrine axis which may have important implications for reproduction and may signal reproductive senescence. Compared to yearly follicular measures of reproductive hormones, daily urine hormone analysis provides a more integrative assessment.

Three groups of subjects will be recruited:

Group 1: Otherwise healthy, mid-reproductive aged women between the ages of 20 and 35 years previously exposed to high dose alkylating agent therapy (or have an alkylator score of 1 or more), and at least 1 year from cancer treatment.

Group 2: healthy, mid-reproductive aged women between the ages of 20 to 35 who have not been exposed to cancer therapy.

Group 3: healthy, late reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility.

Subjects in all groups must have regular menstrual cycles every 21-35 days, and have a uterus and both ovaries. Each participant will complete daily urinary collections for 2 menstrual cycles to assess reproductive hormones. The ultimate goal of this work is to better estimate the reproductive window, or time to menopause.

Conditions

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Effects of Chemotherapy

Keywords

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fertility hormones healthy chemotherapy oncofertility alkylating agent fertility after cancer late effects survivorship healthy volunteers perimenopause middle age

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Otherwise healthy, mid-reproductive aged women between the ages of 20 and 35 years previously exposed to high dose alkylating agent therapy (or have an alkylator score of 1 or more), and at least 1 year from cancer treatment.

No interventions assigned to this group

Group 2

Healthy, mid-reproductive aged women between the ages of 20 to 35 who have not been exposed to cancer therapy.

No interventions assigned to this group

Group 3

Reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Otherwise healthy, mid-reproductive aged women between the ages of 20 and 35 years previously exposed to high dose alkylating agent therapy (or have an alkylator score of 1 or more), and at least 1 year from cancer treatment.


* Healthy, mid-reproductive aged women between the ages of 20 to 35 who have not been exposed to cancer therapy.


* Healthy, late reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility.

Exclusion Criteria

* Pregnancy or lactation within the previous 3 months
* Use of hormonal contraception or replacement within the previous 3 months
* Body Mass Index greater than 30 kg/m2
* Excessive exercise greater than 1 hour per day
* Any medical condition other than cancer known to be associated with premature ovarian failure (such as Turners Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushings syndrome, hyperprolactinemia, and polycystic ovary syndrome)
Minimum Eligible Age

20 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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Clarisa R Gracia, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania, Reproductive Research Unit

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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811323

Identifier Type: -

Identifier Source: org_study_id