Clinical trial NCT03197532: Assessing Urinary Hormones in Female Cancer Survivors
Official title: Follicular and Luteal Dysfunction in Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effects of Chemotherapy
Keywords: fertility
hormones
healthy
chemotherapy
oncofertility
alkylating agent
fertility after cancer
late effects
survivorship
healthy volunteers
perimenopause
middle age
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 38
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Regularly menstruating postmenarchal, mid-reproductive aged female cancer patients treated with high dose alkylating agent chemotherapy or with an alkylator score of 1 or more.
* Unexposed, regularly menstruating mid-reproductive aged women, and unexposed, regularly menstruating late reproductive aged women.

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Urinary Follicle Stimulating Hormone (FSH)
timeFrame: up to 49 days each menstrual cycle
measure: Urinary Luteinizing Hormone (LH)
timeFrame: up to 49 days each menstrual cycle
measure: Urinary Estrone Conjugate (E1C)
timeFrame: up to 49 days each menstrual cycle
measure: Urinary Pregnanediol-glucuronide
timeFrame: up to 49 days each menstrual cycle
measure: Urinary Creatinine
timeFrame: up to 49 days each menstrual cycle
Secondary outcomes:
measure: Luteal and follicular phase lengths
timeFrame: up to 49 days each menstrual cycle
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, Reproductive Research Unit
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania, Reproductive Research Unit
name: Clarisa R Gracia, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: