Effects of ChemotherapyNCT01143844
Assessing Fertility Potential in Female Cancer Survivors
An observational study of Effects of Chemotherapy, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience endocrine changes more similar to women in their late reproductive years than to same-age peers. These changes will be more dramatic in women who receive high dose therapy compared to women who receive low dose therapy. Read more about this study
- Who is it for?
- Ages 11 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of Chemotherapy
- Type of treatment
- Pill or oral medicine
- How many people
- 391 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to 30 Mar 2020
- 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 11 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects with a history of cancer, or other conditions treated by chemotherapy, will be identified through local survivorship programs or self-referral. In addition, two groups of regularly menstruating unexposed subjects will be recruited through local advertising: a group of similar-age subjects and another group in the late reproductive years. Exposed and unexposed controls will be frequency matched with respect to age (within 2 years) at enrollment. In addition,subjects will be balanced with respect to self reported race/ethnicity. Enrollment is purposefully targeted and stratified for this study to reflect the population in the pediatric and adult oncology practices.
Who may be able to join
- Previous treatment with chemotherapy and/or radiation therapy for either cancer or another illness.
- Age between 11-35 years.
- Post-menarchal.
- Presence of a uterus and at least one ovary.
- Ability and willingness to comply with study protocol.
- Have given written informed consent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Show all 12Show fewer
- Healthy females who have never been treated for cancer.
- Age between 11-35 and 40-50 years.
- Post-menarchal with regular cyclic menses (every 21-35 days)
- Presence of a uterus and at least 1 ovary.
- Ability and willingness to comply with study protocol.
- Have given written informed concent, prior to any study-related procedure, not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Who cannot join
- Current pregnancy.
- Use of hormonal contraception or use of hormone replacement therapy within the previous 4 weeks.
- Lactation within the previous 3 months.
- Chronic illness that would limit ability of participant to comply with study protocol.
- Any known medical condition, other than cancer, which in the judgement of the investigator is known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, adrenal dysfunction, Cushing's syndrome, hyperprolactinemia, and polycystic ovarian syndrome).
- For controls, a history of infertility.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Penn Reproductive Research Unit, 3701 Market Street, Suite 810
Philadelphia, Pennsylvania, 19104
Penn Medicine at Radnor, 250 King of Prussia Road
Radnor, Pennsylvania, 19087
About this study
Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience endocrine changes more similar to women in their late reproductive years than to same-age peers. These changes will be more dramatic in women who receive high dose therapy compared to women who receive low dose therapy.
At annual visits over 3-5 years, a combination of physical exam, medical history, menstrual diary keeping, pelvic ultrasound and blood hormones tests will be used to measure "ovarian reserve" , that is the number and quality of the eggs that remain in the ovaries. The study will also try to learn if those who received higher doses of certain chemotherapies are more likely to have changes in these tests sooner than those women who received smaller doses of these same drugs. Additionally a DNA (deoxyribonucleic acid) sample will be collected to look for gene variations that may predict susceptibility to ovarian damage from cancer treatments. Information learned from this study may help researchers to develop guidelines to identify problems with a female cancer survivor's ovaries before irregular menses or other symptoms of ovarian failure occur.
Read the detailed description
Up to 400 females will participate in this study in one of three cohorts:
- 150 females ages 11-35, with history of exposure to alkylating agent chemotherapy and/or radiation therapy
- 150 Unexposed peers, ages 11-35, never exposed to chemotherapy or radiation therapy
- 100 Unexposed females, ages 40-50 never exposed to chemotherapy or radiation therapy
- Conditions
- Effects of Chemotherapy
- Keywords
- Oncofertility, Fertility, Late effects, cancer, chemotherapy, radiation therapy, survivor, ovarian reserve, premature ovarian failure, early menopause, healthy volunteers, perimenopause, middle age, pediatric survivors, healthy women
- Medical subject headings
- Neoplasms, Primary Ovarian Insufficiency
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 |
|---|---|---|
| Exposed females, ages 11-40 | * Prior exposure to alkylating agent chemotherapy and/or radiation therapy * At least 1 year from completion of chemotherapy and/or radiation therapy * Uterus and at least one ovary are present * Not pregnant or breastfeeding in the past 3 months * Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits * No medical condition (other than cancer) known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome). | |
| Unexposed females, ages 40-50 | * Never exposed to chemotherapy or radiation therapy * Regular menstrual cycle (every 21-35 days) * Uterus and at least one ovary are present * Not pregnant or breastfeeding in the past 3 months * Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits * No medical condition known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome). | |
| Unexposed females, ages 11-35 | * Never exposed to chemotherapy or radiation therapy * Regular menstrual cycle (every 21-35 days) * Uterus and at least one ovary are present * Not pregnant or breastfeeding in the past 3 months * Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits * No medical condition known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproductive hormones
Primary Outcomes for this study will include mean and changes in reproductive hormone measures obtained during the early follicular phase of the menstrual cycle (days 1-4).
Measured: Annually for 3-5 years
Secondary outcomes (1)
Antral Follicle Counts
All ovarian follicles and cysts will be measured by transvaginal or transabdominal ultrasound. Follicles will be measured in millimeters and grouped according to size: 2-5 mm, 6-9 mm, and >10 mm in diameter.
Measured: Annually for 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startMar 2006
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Clarisa R Gracia, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143844
- Sponsor's protocol ID
- 804237
- Other IDs
- UPCC12807
- Status last verified
- Apr 2021
- First submitted
- 11 Jun 2010
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be shared with Dr. Jill Ginsberg, a co-investigator of the study.
Publications
Gracia CR, Sammel MD, Freeman E, Prewitt M, Carlson C, Ray A, Vance A, Ginsberg JP. Impact of cancer therapies on ovarian reserve. Fertil Steril. 2012 Jan;97(1):134-40.e1. doi: 10.1016/j.fertnstert.2011.10.040. Epub 2011 Dec 2.
PubMed 22137491
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Fertility Potential in Female Cancer Survivors
- ClinicalTrials.gov ID
- NCT01143844
- Acronym / sponsor ID
- 804237
- Conditions
- Effects of Chemotherapy
- Keywords
- Oncofertility, Fertility, Late effects, cancer, chemotherapy, radiation therapy, survivor, ovarian reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- Mar 2006 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 14 Jun 2010 (estimated)
- 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.
Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience endocrine changes more similar to women in their late reproductive years than to same-age peers. These changes will be more dramatic in women who receive high dose therapy compared to women who receive low dose therapy.
At annual visits over 3-5 years, a combination of physical exam, medical history, menstrual diary keeping, pelvic ultrasound and blood hormones tests will be used to measure "ovarian reserve" , that is the number and quality of the eggs that remain in the ovaries. The study will also try to learn if those who received higher doses of certain chemotherapies are more likely to have changes in these tests sooner than those women who received smaller doses of these same drugs. Additionally a DNA (deoxyribonucleic acid) sample will be collected to look for gene variations that may predict susceptibility to ovarian damage from cancer treatments. Information learned from this study may help researchers to develop guidelines to identify problems with a female cancer survivor's ovaries before irregular menses or other symptoms of ovarian failure occur.
Detailed description
Up to 400 females will participate in this study in one of three cohorts:
- 150 females ages 11-35, with history of exposure to alkylating agent chemotherapy and/or radiation therapy
- 150 Unexposed peers, ages 11-35, never exposed to chemotherapy or radiation therapy
- 100 Unexposed females, ages 40-50 never exposed to chemotherapy or radiation therapy
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exposed females, ages 11-40 | – | –* Prior exposure to alkylating agent chemotherapy and/or radiation therapy * At least 1 year from completion of chemotherapy and/or radiation therapy * Uterus and at least one ovary are present * Not pregnant or breastfeeding in the past 3 months * Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits * No medical condition (other than cancer) known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome). |
| Unexposed females, ages 40-50 | – | –* Never exposed to chemotherapy or radiation therapy * Regular menstrual cycle (every 21-35 days) * Uterus and at least one ovary are present * Not pregnant or breastfeeding in the past 3 months * Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits * No medical condition known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome). |
| Unexposed females, ages 11-35 | – | –* Never exposed to chemotherapy or radiation therapy * Regular menstrual cycle (every 21-35 days) * Uterus and at least one ovary are present * Not pregnant or breastfeeding in the past 3 months * Not taking any hormones or oral contraceptives for at least 4 weeks prior to study visits * No medical condition known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinemia, and polycystic ovary syndrome). |
Who may qualify
- Ages
- 11 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects with a history of cancer, or other conditions treated by chemotherapy, will be identified through local survivorship programs or self-referral. In addition, two groups of regularly menstruating unexposed subjects will be recruited through local advertising: a group of similar-age subjects and another group in the late reproductive years. Exposed and unexposed controls will be frequency matched with respect to age (within 2 years) at enrollment. In addition,subjects will be balanced with respect to self reported race/ethnicity. Enrollment is purposefully targeted and stratified for this study to reflect the population in the pediatric and adult oncology practices.
Key inclusion criteria (12 listed)
- Previous treatment with chemotherapy and/or radiation therapy for either cancer or another illness.
- Age between 11-35 years.
- Post-menarchal.
- Presence of a uterus and at least one ovary.
- Ability and willingness to comply with study protocol.
Key exclusion criteria (6 listed)
- Current pregnancy.
- Use of hormonal contraception or use of hormone replacement therapy within the previous 4 weeks.
- Lactation within the previous 3 months.
- Chronic illness that would limit ability of participant to comply with study protocol.
- Any known medical condition, other than cancer, which in the judgement of the investigator is known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, adrenal dysfunction, Cushing's syndrome, hyperprolactinemia, and polycystic ovarian 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
Reproductive hormones
Time frame: Annually for 3-5 years
Primary Outcomes for this study will include mean and changes in reproductive hormone measures obtained during the early follicular phase of the menstrual cycle (days 1-4).
1 secondary outcome
Antral Follicle Counts
Time frame: Annually for 3-5 years
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 13 Apr 2021.
- Background: PubMed 22137491Gracia CR, Sammel MD, Freeman E, Prewitt M, Carlson C, Ray A, Vance A, Ginsberg JP. Impact of cancer therapies on ovarian reserve. Fertil Steril. 2012 Jan;97(1):134-40.e1. doi: 10.1016/j.fertnstert.2011.10.040. Epub 2011 Dec 2.
- Select "Clinical Trials" for Current Studies at Penn's Women's Health Clinical Research Center.For more information about participating in one of Penn Fertility Care's research studies please call 1-800-789-PENN.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be shared with Dr. Jill Ginsberg, a co-investigator of the study.
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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
2 sites 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 2 sites 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 12 inclusion and 6 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Reproductive hormones (time frame: Annually for 3-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01143844, which also lists 1 linked publication.
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 13 Apr 2021.