Effects of ChemotherapyORACLENCT02467231
Ovarian Reserve After Cancer: Longitudinal Effects
An observational study of Effects of Chemotherapy and Premature Ovarian Failure, run by University of Pennsylvania at 1 site in United States.
Trial summary
Women of reproductive age who will receive treatment for cancer that includes chemotherapy may participate in a study measuring ovarian function over time. Eligible women are asked to complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and a blood test before, during and after… Read more about this study
- Who is it for?
- Ages 11 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effects of Chemotherapy, Premature Ovarian Failure
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Postmenarchal females, ages 11-35, who will require chemotherapy; An unexposed cohort balanced to the exposed cohort with respect to age and oral contraceptive use.
Who may be able to join
- Postmenarchal females to be treated with chemotherapy
- between the ages of 11-35 years,
- with a uterus and at least one ovary
- healthy postmenarchal females
- no prior or planned exposure to chemotherapy
- between the ages of 11-35,
- with a uterus and at least one ovary
- regular menstrual cycles (21-35 days)
Who cannot join
- positive pregnancy test at enrollment
- lactation within the previous 1 month,
- previous treatment with chemotherapy or radiation therapy with the exception of radioactive iodine for thyroid cancer.
- previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier)
- endocrine disorder associated with irregular menstrual cycles (Cushing's disease, Thyroid disease, hyper-prolactinemia, congenital adrenal hyperplasia).
- Additional exclusions for the unexposed population:
- a history of infertility, defined as at least 12 months of unprotected intercourse without conception
- polycystic ovary syndrome (PCOS)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania, Reproductive Research Unit
Philadelphia, Pennsylvania, 19104-5509
About this study
Official title: Ovarian Reserve After Cancer: Longitudinal Effects A Multicenter Prospective Cohort Study by the Oncofertility Consortium
Women of reproductive age who will receive treatment for cancer that includes chemotherapy may participate in a study measuring ovarian function over time. Eligible women are asked to complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and a blood test before, during and after cancer treatment.
Read the detailed description
A total of 7 study visits will be completed at 3 month intervals including 1 visit prior to treatment, and at least 2 visits after completion of treatment. Duration of study participation is 18-30 months, depending on length of treatment.
Review and Documentation of Cancer Therapy will be abstracted from the clinical oncology chart by the oncology offices caring for the patient. Treatment will be summarized in terms of chemotherapeutic type, duration and cumulative dose; total radiation dose and location; history and type of bone marrow transplantation; and any surgery. Any attempts at fertility preservation or use of gonadotropin releasing hormone agonist treatment during cancer therapy will be captured as well.
- Conditions
- Effects of Chemotherapy, Premature Ovarian Failure
- Keywords
- new diagnosis of cancer, chemotherapy, oncofertility, alkylating agent, fertility preservation, fertility after cancer, late effects
- Medical subject headings
- 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 11-35 to be exposed to alkylating agent chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in reproductive hormone measures, during and after chemotherapy.
20 mls blood will be obtained at stated timepoints for determining levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Inhibin B, and Anti-mullerian Hormone (AMH). In menstruating girls and young women hormone measures will be obtained during the early follicular phase of the menstrual cycle (days 1-4). In women with irregular cycles the testing will be done spontaneously without regard for the bleeding pattern.
Measured: 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.
Secondary outcomes (1)
Change from baseline in antral follicle counts, during and after chemotherapy.
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: 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startFeb 2009
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 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
- NCT02467231
- Sponsor's protocol ID
- 809406
- Acronym
- ORACLE
- Status last verified
- Oct 2025
- First submitted
- 22 Jul 2013
- Last updated
- 28 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Dillon KE, Sammel MD, Prewitt M, Ginsberg JP, Walker D, Mersereau JE, Gosiengfiao Y, Gracia CR. Pretreatment antimullerian hormone levels determine rate of posttherapy ovarian reserve recovery: acute changes in ovarian reserve during and after chemotherapy. Fertil Steril. 2013 Feb;99(2):477-83. doi: 10.1016/j.fertnstert.2012.09.039. Epub 2012 Oct 18.
PubMed 23084267Cameron K, Sammel MD, Prewitt M, Gracia C. Differential Rates of Change in Measures of Ovarian Reserve in Young Cancer Survivors Across the Reproductive Lifespan. J Clin Endocrinol Metab. 2019 May 1;104(5):1813-1822. doi: 10.1210/jc.2018-02257.
PubMed 30566616
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Reserve After Cancer: Longitudinal Effects A Multicenter Prospective Cohort Study by the Oncofertility Consortium
- ClinicalTrials.gov ID
- NCT02467231
- Acronym / sponsor ID
- ORACLE / 809406
- Conditions
- Effects of Chemotherapy, Premature Ovarian Failure
- Keywords
- new diagnosis of cancer, chemotherapy, oncofertility, alkylating agent, fertility preservation, fertility after cancer, late effects
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- Feb 2009
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Jun 2015 (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.
Women of reproductive age who will receive treatment for cancer that includes chemotherapy may participate in a study measuring ovarian function over time. Eligible women are asked to complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and a blood test before, during and after cancer treatment.
Detailed description
A total of 7 study visits will be completed at 3 month intervals including 1 visit prior to treatment, and at least 2 visits after completion of treatment. Duration of study participation is 18-30 months, depending on length of treatment.
Review and Documentation of Cancer Therapy will be abstracted from the clinical oncology chart by the oncology offices caring for the patient. Treatment will be summarized in terms of chemotherapeutic type, duration and cumulative dose; total radiation dose and location; history and type of bone marrow transplantation; and any surgery. Any attempts at fertility preservation or use of gonadotropin releasing hormone agonist treatment during cancer therapy will be captured as well.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | –Females ages 11-35 to be exposed to alkylating agent chemotherapy |
Who may qualify
- Ages
- 11 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Postmenarchal females, ages 11-35, who will require chemotherapy; An unexposed cohort balanced to the exposed cohort with respect to age and oral contraceptive use.
Key inclusion criteria (8 listed)
- Postmenarchal females to be treated with chemotherapy
- between the ages of 11-35 years,
- with a uterus and at least one ovary
- healthy postmenarchal females
- no prior or planned exposure to chemotherapy
Key exclusion criteria (8 listed)
- positive pregnancy test at enrollment
- lactation within the previous 1 month,
- previous treatment with chemotherapy or radiation therapy with the exception of radioactive iodine for thyroid cancer.
- previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier)
- endocrine disorder associated with irregular menstrual cycles (Cushing's disease, Thyroid disease, hyper-prolactinemia, congenital adrenal hyperplasia).
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
Change from baseline in reproductive hormone measures, during and after chemotherapy.
Time frame: 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.
20 mls blood will be obtained at stated timepoints for determining levels of Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Inhibin B, and Anti-mullerian Hormone (AMH). In menstruating girls and young women hormone measures will be obtained during the early follicular phase of the menstrual cycle (days 1-4). In women with irregular cycles the testing will be done spontaneously without regard for the bleeding pattern.
1 secondary outcome
Change from baseline in antral follicle counts, during and after chemotherapy.
Time frame: 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2025.
- Background: PubMed 23084267Dillon KE, Sammel MD, Prewitt M, Ginsberg JP, Walker D, Mersereau JE, Gosiengfiao Y, Gracia CR. Pretreatment antimullerian hormone levels determine rate of posttherapy ovarian reserve recovery: acute changes in ovarian reserve during and after chemotherapy. Fertil Steril. 2013 Feb;99(2):477-83. doi: 10.1016/j.fertnstert.2012.09.039. Epub 2012 Oct 18.
- Derived from this study: PubMed 30566616Cameron K, Sammel MD, Prewitt M, Gracia C. Differential Rates of Change in Measures of Ovarian Reserve in Young Cancer Survivors Across the Reproductive Lifespan. J Clin Endocrinol Metab. 2019 May 1;104(5):1813-1822. doi: 10.1210/jc.2018-02257.
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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
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 and Premature Ovarian Failure, 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 8 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in reproductive hormone measures, during and after chemotherapy. (time frame: 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.). 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 NCT02467231, which also lists 2 linked publications.
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 28 Oct 2025.