Assessing Urinary Hormones in Female Cancer Survivors

Effects of Chemotherapy Clinical Trial

— AUHS  

Official title:

Follicular and Luteal Dysfunction in Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197532
• Other study ID #: 811323
• Status: Completed
• Start date: January 2011
• Est. completion date: May 2016

Study information

• Verified date: November 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria for 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.

Inclusion Criteria for Group 2:

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

Inclusion Criteria for 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.

Exclusion Criteria for all subjects:

• 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)

Related Conditions & MeSH terms

• Effects of Chemotherapy

Locations

Country	Name	City	State
United States	University of Pennsylvania, Reproductive Research Unit	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Follicle Stimulating Hormone (FSH)	Integrated urinary follicular-phase Follicle Stimulating Hormone (FSH) in urine samples collected daily for 2 menstrual cycles will be measured in mIU/mL by means of two-site chemiluminescent immunoassay with the use of two monoclonal antibodies.	up to 49 days each menstrual cycle
Primary	Urinary Luteinizing Hormone (LH)	Integrated urinary follicular-phase Luteinizing Hormone (LH) in urine samples collected daily for 2 menstrual cycles will be measured in mIU/mL by means of two-site chemiluminescent immunoassay with the use of two monoclonal antibodies.	up to 49 days each menstrual cycle
Primary	Urinary Estrone Conjugate (E1C)	Estrone Conjugate (E1C) in urine samples collected daily for 2 menstrual cycles will be measured in ug/dL by means of E1C immunoassay.	up to 49 days each menstrual cycle
Primary	Urinary Pregnanediol-glucuronide	Pregnanediol-glucuronide (PDG) in urine samples collected daily for 2 menstrual cycles will be measured in ug/mL by means of PDG immunoassay.	up to 49 days each menstrual cycle
Primary	Urinary Creatinine	Urinary Creatinine in urine samples collected daily for 2 menstrual cycles will be measured in mg/mL by means of spectrophotometric assay.	up to 49 days each menstrual cycle
Secondary	Luteal and follicular phase lengths	Participants will be provided with calendars on which to record detailed menstrual cycle information during the study. The total menstrual cycle length will be defined as the number of days from day 1 of menses to the day before the next menses. The Kassam method will be used to determine evidence of luteal activity, presumably ovulation. Follicular phase will be defined as the number of days from day 1 of menses up to the day of luteal transition and the luteal phase length will be defined as the number of days beginning from the day after the day of luteal transition to the day before the next menses.	up to 49 days each menstrual cycle