{
"info": {
"nct_id": "NCT02467231",
"official_title": "Ovarian Reserve After Cancer: Longitudinal Effects A Multicenter Prospective Cohort Study by the Oncofertility Consortium",
"inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 11 Years\nMust have maximum age of 35 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "Inclusion Criteria for exposed population:\n\n* Postmenarchal females to be treated with chemotherapy\n* between the ages of 11-35 years,\n* with a uterus and at least one ovary\n\nInclusion Criteria for unexposed population:\n\n* healthy postmenarchal females\n* no prior or planned exposure to chemotherapy\n* between the ages of 11-35,\n* with a uterus and at least one ovary\n* regular menstrual cycles (21-35 days)\n\nExclusion criteria for all subjects:\n\n* positive pregnancy test at enrollment\n* lactation within the previous 1 month,\n* previous treatment with chemotherapy or radiation therapy with the exception of radioactive iodine for thyroid cancer.\n* previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier)\n* endocrine disorder associated with irregular menstrual cycles (Cushing's disease, Thyroid disease, hyper-prolactinemia, congenital adrenal hyperplasia).\n\nAdditional exclusions for the unexposed population:\n\n* a history of infertility, defined as at least 12 months of unprotected intercourse without conception\n* polycystic ovary syndrome (PCOS)"
},
"inclusion_lines": [
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 11 Years",
"criterions": [
{
"exact_snippets": "minimum age of 11 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 11,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 11 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 11,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 35 Years",
"criterions": [
{
"exact_snippets": "maximum age of 35 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 35,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 35 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 35,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"identified_line": {
"line": "Inclusion Criteria for exposed population:",
"criterions": [
{
"exact_snippets": "exposed population",
"criterion": "population exposure",
"requirement": {
"requirement_type": "exposure",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "exposed population",
"criterion": "population exposure",
"requirement": {
"requirement_type": "exposure",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Postmenarchal females to be treated with chemotherapy",
"criterions": [
{
"exact_snippets": "Postmenarchal females",
"criterion": "postmenarchal status",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenarchal"
}
},
{
"exact_snippets": "females",
"criterion": "gender",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
},
{
"exact_snippets": "to be treated with chemotherapy",
"criterion": "treatment plan",
"requirement": {
"requirement_type": "treatment",
"expected_value": "chemotherapy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Postmenarchal females",
"criterion": "postmenarchal status",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenarchal"
}
},
{
"exact_snippets": "females",
"criterion": "gender",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
}
]
},
{
"exact_snippets": "to be treated with chemotherapy",
"criterion": "treatment plan",
"requirement": {
"requirement_type": "treatment",
"expected_value": "chemotherapy"
}
}
]
}
},
{
"identified_line": {
"line": "* between the ages of 11-35 years,",
"criterions": [
{
"exact_snippets": "between the ages of 11-35 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 11,
"unit": "years"
},
{
"operator": "<=",
"value": 35,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "between the ages of 11-35 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 11,
"unit": "years"
},
{
"operator": "<=",
"value": 35,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* with a uterus and at least one ovary",
"criterions": [
{
"exact_snippets": "with a uterus",
"criterion": "uterus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at least one ovary",
"criterion": "ovary",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "ovary"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "with a uterus",
"criterion": "uterus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at least one ovary",
"criterion": "ovary",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "ovary"
}
}
}
]
}
},
{
"identified_line": {
"line": "* healthy postmenarchal females",
"criterions": [
{
"exact_snippets": "healthy",
"criterion": "health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
},
{
"exact_snippets": "postmenarchal",
"criterion": "menstrual status",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenarchal"
}
},
{
"exact_snippets": "females",
"criterion": "gender",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "healthy",
"criterion": "health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
},
{
"exact_snippets": "postmenarchal",
"criterion": "menstrual status",
"requirement": {
"requirement_type": "status",
"expected_value": "postmenarchal"
}
},
{
"exact_snippets": "females",
"criterion": "gender",
"requirement": {
"requirement_type": "gender",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "* no prior or planned exposure to chemotherapy",
"criterions": [
{
"exact_snippets": "no prior or planned exposure to chemotherapy",
"criterion": "chemotherapy exposure",
"requirement": {
"requirement_type": "prior exposure",
"expected_value": false
}
},
{
"exact_snippets": "no prior or planned exposure to chemotherapy",
"criterion": "chemotherapy exposure",
"requirement": {
"requirement_type": "planned exposure",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "no prior or planned exposure to chemotherapy",
"criterion": "chemotherapy exposure",
"requirement": {
"requirement_type": "prior exposure",
"expected_value": false
}
},
{
"exact_snippets": "no prior or planned exposure to chemotherapy",
"criterion": "chemotherapy exposure",
"requirement": {
"requirement_type": "planned exposure",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* between the ages of 11-35,",
"criterions": [
{
"exact_snippets": "between the ages of 11-35",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 11,
"unit": "years"
},
{
"operator": "<=",
"value": 35,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "between the ages of 11-35",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 11,
"unit": "years"
},
{
"operator": "<=",
"value": 35,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* with a uterus and at least one ovary",
"criterions": [
{
"exact_snippets": "with a uterus",
"criterion": "uterus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at least one ovary",
"criterion": "ovary",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "with a uterus",
"criterion": "uterus",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "at least one ovary",
"criterion": "ovary",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* regular menstrual cycles (21-35 days)",
"criterions": [
{
"exact_snippets": "regular menstrual cycles (21-35 days)",
"criterion": "menstrual cycle length",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 21,
"unit": "days"
},
{
"operator": "<=",
"value": 35,
"unit": "days"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "regular menstrual cycles (21-35 days)",
"criterion": "menstrual cycle length",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 21,
"unit": "days"
},
{
"operator": "<=",
"value": 35,
"unit": "days"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* positive pregnancy test at enrollment",
"criterions": [
{
"exact_snippets": "positive pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "positive"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "positive pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "positive"
}
}
]
}
},
{
"identified_line": {
"line": "* lactation within the previous 1 month,",
"criterions": [
{
"exact_snippets": "lactation within the previous 1 month",
"criterion": "lactation",
"requirement": {
"requirement_type": "time since last occurrence",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "lactation within the previous 1 month",
"criterion": "lactation",
"requirement": {
"requirement_type": "time since last occurrence",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "month"
}
}
}
]
}
},
{
"identified_line": {
"line": "* previous treatment with chemotherapy or radiation therapy with the exception of radioactive iodine for thyroid cancer.",
"criterions": [
{
"exact_snippets": "previous treatment with chemotherapy",
"criterion": "previous chemotherapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "previous treatment with ... radiation therapy",
"criterion": "previous radiation therapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "exception of radioactive iodine for thyroid cancer",
"criterion": "radioactive iodine treatment for thyroid cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "previous treatment with chemotherapy",
"criterion": "previous chemotherapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "previous treatment with ... radiation therapy",
"criterion": "previous radiation therapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "exception of radioactive iodine for thyroid cancer",
"criterion": "radioactive iodine treatment for thyroid cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier)",
"criterions": [
{
"exact_snippets": "previous diagnosis of an illness associated with premature ovarian failure",
"criterion": "illness associated with premature ovarian failure",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "Turner's syndrome",
"criterion": "Turner's syndrome",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "Fragile X permutation carrier",
"criterion": "Fragile X permutation carrier",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "previous diagnosis of an illness associated with premature ovarian failure",
"criterion": "illness associated with premature ovarian failure",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "Turner's syndrome",
"criterion": "Turner's syndrome",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "previous diagnosis of an illness associated with premature ovarian failure",
"criterion": "illness associated with premature ovarian failure",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
},
{
"exact_snippets": "Fragile X permutation carrier",
"criterion": "Fragile X permutation carrier",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* endocrine disorder associated with irregular menstrual cycles (Cushing's disease, Thyroid disease, hyper-prolactinemia, congenital adrenal hyperplasia).",
"criterions": [
{
"exact_snippets": "endocrine disorder associated with irregular menstrual cycles",
"criterion": "endocrine disorder",
"requirement": {
"requirement_type": "association",
"expected_value": "irregular menstrual cycles"
}
},
{
"exact_snippets": "Cushing's disease",
"criterion": "Cushing's disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Thyroid disease",
"criterion": "Thyroid disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hyper-prolactinemia",
"criterion": "hyper-prolactinemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "congenital adrenal hyperplasia",
"criterion": "congenital adrenal hyperplasia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "endocrine disorder associated with irregular menstrual cycles",
"criterion": "endocrine disorder",
"requirement": {
"requirement_type": "association",
"expected_value": "irregular menstrual cycles"
}
},
{
"or_criteria": [
{
"exact_snippets": "Cushing's disease",
"criterion": "Cushing's disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Thyroid disease",
"criterion": "Thyroid disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "hyper-prolactinemia",
"criterion": "hyper-prolactinemia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "congenital adrenal hyperplasia",
"criterion": "congenital adrenal hyperplasia",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "Additional exclusions for the unexposed population:",
"criterions": [
{
"exact_snippets": "unexposed population",
"criterion": "population exposure status",
"requirement": {
"requirement_type": "exposure",
"expected_value": "unexposed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "unexposed population",
"criterion": "population exposure status",
"requirement": {
"requirement_type": "exposure",
"expected_value": "unexposed"
}
}
]
}
},
{
"identified_line": {
"line": "* a history of infertility, defined as at least 12 months of unprotected intercourse without conception",
"criterions": [
{
"exact_snippets": "a history of infertility, defined as at least 12 months of unprotected intercourse without conception",
"criterion": "infertility",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "a history of infertility, defined as at least 12 months of unprotected intercourse without conception",
"criterion": "infertility",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "months"
}
}
}
]
}
},
{
"identified_line": {
"line": "* polycystic ovary syndrome (PCOS)",
"criterions": [
{
"exact_snippets": "polycystic ovary syndrome (PCOS)",
"criterion": "polycystic ovary syndrome (PCOS)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "polycystic ovary syndrome (PCOS)",
"criterion": "polycystic ovary syndrome (PCOS)",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Inclusion Criteria for unexposed population:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
},
{
"identified_line": {
"line": "Exclusion criteria for all subjects:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}