Effects of ChemotherapyAUHSNCT03197532
Assessing Urinary Hormones in Female Cancer Survivors
An observational study of Effects of Chemotherapy, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of Chemotherapy
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Reproductive Research Unit
Philadelphia, Pennsylvania, 19104
About this study
Official title: Follicular and Luteal Dysfunction in Cancer Survivors
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.
Read the 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.
- Conditions
- Effects of Chemotherapy
- Keywords
- fertility, hormones, healthy, chemotherapy, oncofertility, alkylating agent, fertility after cancer, late effects, survivorship, healthy volunteers, perimenopause, middle age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | Reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 49 days each menstrual cycle
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.
Measured: up to 49 days each menstrual cycle
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.
Measured: up to 49 days each menstrual cycle
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.
Measured: up to 49 days each menstrual cycle
Urinary Creatinine
Urinary Creatinine in urine samples collected daily for 2 menstrual cycles will be measured in mg/mL by means of spectrophotometric assay.
Measured: up to 49 days each menstrual cycle
Secondary outcomes (1)
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.
Measured: up to 49 days each menstrual cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study startJan 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of ChemotherapyStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clarisa R Gracia, MD, MSCE, Principal investigator, University of Pennsylvania, Reproductive Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197532
- Sponsor's protocol ID
- 811323
- Acronym
- AUHS
- Status last verified
- Nov 2020
- First submitted
- 22 Jul 2013
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follicular and Luteal Dysfunction in Cancer Survivors
- ClinicalTrials.gov ID
- NCT03197532
- Acronym / sponsor ID
- AUHS / 811323
- Conditions
- Effects of Chemotherapy
- Keywords
- fertility, hormones, healthy, chemotherapy, oncofertility, alkylating agent, fertility after cancer, late effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | –Reproductive aged women between the ages of 43-50 who have not been exposed to cancer therapy, nor have a history of infertility |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urinary Follicle Stimulating Hormone (FSH)
Time frame: up to 49 days each menstrual cycle
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.
Urinary Luteinizing Hormone (LH)
Time frame: up to 49 days each menstrual cycle
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.
Urinary Estrone Conjugate (E1C)
Time frame: up to 49 days each menstrual cycle
Estrone Conjugate (E1C) in urine samples collected daily for 2 menstrual cycles will be measured in ug/dL by means of E1C immunoassay.
Urinary Pregnanediol-glucuronide
Time frame: up to 49 days each menstrual cycle
Pregnanediol-glucuronide (PDG) in urine samples collected daily for 2 menstrual cycles will be measured in ug/mL by means of PDG immunoassay.
Urinary Creatinine
Time frame: up to 49 days each menstrual cycle
Urinary Creatinine in urine samples collected daily for 2 menstrual cycles will be measured in mg/mL by means of spectrophotometric assay.
1 secondary outcome
Luteal and follicular phase lengths
Time frame: up to 49 days each menstrual cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clarisa R Gracia, MD, MSCE principal investigator
University of Pennsylvania, Reproductive Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effects of Chemotherapy, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Follicle Stimulating Hormone (FSH) (time frame: up to 49 days each menstrual cycle). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.