ID

40398

Description

Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin; ODM derived from: https://clinicaltrials.gov/show/NCT01403688

Link

https://clinicaltrials.gov/show/NCT01403688

Keywords

Versions (1)
  1. 4/18/20 4/18/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 18, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Infertility NCT01403688

English

Eligibility Infertility NCT01403688

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. women must be at increased risk for breast cancer based on any of the following criteria:
Description

Gender | High risk of Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0678222
age 30 or older with no prior live birth.
Description

Age | Live Birth Previous Absent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0481667
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0332197
mutations associated with hereditary cancer (brca1 or 2, p53, pten)
Description

Mutations Associated with Hereditary Malignant Neoplasm | BRCA1 gene mutation | BRCA2 gene mutation | TP53 Gene Mutation | PTEN gene mutation

Data type

boolean

Alias
UMLS CUI [1,1]
C0026882
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1333600
UMLS CUI [2]
C1511022
UMLS CUI [3]
C1511024
UMLS CUI [4]
C3897380
UMLS CUI [5]
C3267001
family history of breast cancer including one first degree or multiple second degree relatives
Description

Family history of breast cancer | First Degree Relative Quantity | Second Degree Relative multiple

Data type

boolean

Alias
UMLS CUI [1]
C0559119
UMLS CUI [2,1]
C1517194
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C1519210
UMLS CUI [3,2]
C0439064
history of chest radiation before age 30
Description

Radiotherapy to thorax Before Age

Data type

boolean

Alias
UMLS CUI [1,1]
C4038705
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0001779
multiple prior breast biopsies
Description

Biopsy of breast multiple

Data type

boolean

Alias
UMLS CUI [1,1]
C0405352
UMLS CUI [1,2]
C0439064
precancerous conditions (dcis, lcis, ah)
Description

Precancerous Conditions | DCIS | LCIS | Atypical hyperplasia

Data type

boolean

Alias
UMLS CUI [1]
C0032927
UMLS CUI [2]
C0007124
UMLS CUI [3]
C0279563
UMLS CUI [4]
C0333977
prior history of breast or ovarian cancer
Description

Medical History Breast Carcinoma | Medical History Ovarian neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0919267
estimated mammographic breast density > 50%
Description

Mammographic Breast Density Estimated

Data type

boolean

Alias
UMLS CUI [1,1]
C1268717
UMLS CUI [1,2]
C0750572
2. must be undergoing infertility treatment at the university of kansas with controlled ovarian hyper-stimulation (coh)
Description

Infertility therapy | Controlled ovarian hyperstimulation

Data type

boolean

Alias
UMLS CUI [1]
C0200070
UMLS CUI [2]
C3160882
3. must be between the ages of 21-45 (both inclusive) with day 3 fsh less than 12 iu/l, day 3 e2 less than 80 pg/ml
Description

Age | Follicle stimulating hormone measurement | Estradiol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0202022
UMLS CUI [3]
C0337434
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women under 21 or over 45 years old
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. day 3 fsh over 12 iu/l, day 3 e2 over 80 pg/ml
Description

Follicle stimulating hormone measurement | Estradiol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202022
UMLS CUI [2]
C0337434
3. women who do not meet risk criteria above
Description

Lacking Risk factors Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0035648
UMLS CUI [1,3]
C1550543
4. history of hypersensitivity to letrozole or gonadotropin
Description

Hypersensitivity Letrozole | Gonadotrophic hormone allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0246421
UMLS CUI [2]
C0571726
5. uterine and adnexal pathology
Description

Uterine Diseases | Adnexal Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0042131
UMLS CUI [2]
C0001576
6. use of clomid or gonadotropin within 30days before the letrozole cycle
Description

Clomid | Gonadotropin

Data type

boolean

Alias
UMLS CUI [1]
C0591268
UMLS CUI [2]
C0018061
7. any severe chronic disease of relevance for reproductive function
Description

Chronic disease Severe | Relevance Reproductive function

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C2347946
UMLS CUI [2,2]
C0232896
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Similar models

Eligibility Infertility NCT01403688

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | High risk of Breast Carcinoma
Item
1. women must be at increased risk for breast cancer based on any of the following criteria:
boolean
C0079399 (UMLS CUI [1])
C0332167 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Age | Live Birth Previous Absent
Item
age 30 or older with no prior live birth.
boolean
C0001779 (UMLS CUI [1])
C0481667 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Mutations Associated with Hereditary Malignant Neoplasm | BRCA1 gene mutation | BRCA2 gene mutation | TP53 Gene Mutation | PTEN gene mutation
Item
mutations associated with hereditary cancer (brca1 or 2, p53, pten)
boolean
C0026882 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1333600 (UMLS CUI [1,3])
C1511022 (UMLS CUI [2])
C1511024 (UMLS CUI [3])
C3897380 (UMLS CUI [4])
C3267001 (UMLS CUI [5])
Family history of breast cancer | First Degree Relative Quantity | Second Degree Relative multiple
Item
family history of breast cancer including one first degree or multiple second degree relatives
boolean
C0559119 (UMLS CUI [1])
C1517194 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1519210 (UMLS CUI [3,1])
C0439064 (UMLS CUI [3,2])
Radiotherapy to thorax Before Age
Item
history of chest radiation before age 30
boolean
C4038705 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,3])
Biopsy of breast multiple
Item
multiple prior breast biopsies
boolean
C0405352 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
Precancerous Conditions | DCIS | LCIS | Atypical hyperplasia
Item
precancerous conditions (dcis, lcis, ah)
boolean
C0032927 (UMLS CUI [1])
C0007124 (UMLS CUI [2])
C0279563 (UMLS CUI [3])
C0333977 (UMLS CUI [4])
Medical History Breast Carcinoma | Medical History Ovarian neoplasm
Item
prior history of breast or ovarian cancer
boolean
C0262926 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0919267 (UMLS CUI [2,2])
Mammographic Breast Density Estimated
Item
estimated mammographic breast density > 50%
boolean
C1268717 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Infertility therapy | Controlled ovarian hyperstimulation
Item
2. must be undergoing infertility treatment at the university of kansas with controlled ovarian hyper-stimulation (coh)
boolean
C0200070 (UMLS CUI [1])
C3160882 (UMLS CUI [2])
Age | Follicle stimulating hormone measurement | Estradiol measurement
Item
3. must be between the ages of 21-45 (both inclusive) with day 3 fsh less than 12 iu/l, day 3 e2 less than 80 pg/ml
boolean
C0001779 (UMLS CUI [1])
C0202022 (UMLS CUI [2])
C0337434 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Gender | Age
Item
1. women under 21 or over 45 years old
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Follicle stimulating hormone measurement | Estradiol measurement
Item
2. day 3 fsh over 12 iu/l, day 3 e2 over 80 pg/ml
boolean
C0202022 (UMLS CUI [1])
C0337434 (UMLS CUI [2])
Lacking Risk factors Fulfill
Item
3. women who do not meet risk criteria above
boolean
C0332268 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Hypersensitivity Letrozole | Gonadotrophic hormone allergy
Item
4. history of hypersensitivity to letrozole or gonadotropin
boolean
C0020517 (UMLS CUI [1,1])
C0246421 (UMLS CUI [1,2])
C0571726 (UMLS CUI [2])
Uterine Diseases | Adnexal Diseases
Item
5. uterine and adnexal pathology
boolean
C0042131 (UMLS CUI [1])
C0001576 (UMLS CUI [2])
Clomid | Gonadotropin
Item
6. use of clomid or gonadotropin within 30days before the letrozole cycle
boolean
C0591268 (UMLS CUI [1])
C0018061 (UMLS CUI [2])
Chronic disease Severe | Relevance Reproductive function
Item
7. any severe chronic disease of relevance for reproductive function
boolean
C0008679 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2347946 (UMLS CUI [2,1])
C0232896 (UMLS CUI [2,2])
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