ID

40398

Description

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

Lien

https://clinicaltrials.gov/show/NCT01403688

Mots-clés

  1. 18/04/2020 18/04/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

18 avril 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Infertility NCT01403688

Eligibility Infertility NCT01403688

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Precancerous Conditions | DCIS | LCIS | Atypical hyperplasia

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Lacking Risk factors Fulfill

Type de données

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

Type de données

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

Type de données

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

Type de données

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

Type de données

boolean

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

Similar models

Eligibility Infertility NCT01403688

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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