Clinical trial NCT02467231: Ovarian Reserve After Cancer: Longitudinal Effects
Official title: Ovarian Reserve After Cancer: Longitudinal Effects A Multicenter Prospective Cohort Study by the Oncofertility Consortium
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Effects of Chemotherapy
Premature Ovarian Failure
Keywords: new diagnosis of cancer
chemotherapy
oncofertility
alkylating agent
fertility preservation
fertility after cancer
late effects
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2015-06-09
Enrollment: 196
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria for exposed population:

* Postmenarchal females to be treated with chemotherapy
* between the ages of 11-35 years,
* with a uterus and at least one ovary

Inclusion Criteria for unexposed population:

* 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)

Exclusion criteria for all subjects:

* 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)

Primary outcomes:
measure: Change from baseline in reproductive hormone measures, during and after chemotherapy.
timeFrame: 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.
Secondary outcomes:
measure: Change from baseline in antral follicle counts, during and after chemotherapy.
timeFrame: 18-30 months: pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.
Other outcomes:
measure: Change from baseline in menstrual function, during and after chemotherapy
timeFrame: 18-30 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.
measure: Change from baseline in menopausal symptoms during and after chemotherapy.
timeFrame: 18-30 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.
measure: Change from baseline in ovarian volume during and after chemotherapy.
timeFrame: 18-30 months: Pre-chemotherapy baseline and at 3 month intervals from start of chemotherapy through 6 months after end of chemotherapy.
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, Reproductive Research Unit
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Clarisa R Gracia, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Cameron 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.