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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01250821 |
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Date of registration:
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30/11/2010 |
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Primary sponsor: |
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Public title:
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Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility
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Scientific title:
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Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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60 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01250821 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Mette P Lauritsen, MD |
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Address:
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Telephone:
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+45 35451861 |
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Email:
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mette.petri.lauritsen@rh.regionh.dk |
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Affiliation:
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Name:
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Mette P Lauritsen, MD |
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Address:
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Telephone:
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+ 45 35451861 |
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Email:
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mette.petri.lauritsen@rh.regionh.dk |
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Affiliation:
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Name:
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Anders N Andersen, Prof. MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Name:
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Mette P Lauritsen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Anovulatory infertility
2. Age 18 - 39 years
3. Anovulation with oligomenorrhoea (> 35 days of mean cycle length) or amenorrhoea
4. Normal serum FSH (< 10 IU/l)
5. Two ovaries
6. BMI < 35
7. First FSH/HMG cycle at the Fertility clinic.
8. A sperm sample compatible with conception or semen from a donor.
9. Tubal patency documented by either hysterosalpingography (HSG) or
hysterosalpingography by ultrasound (HSU) in cases where the woman has had a pelvic
infection or pelvic surgery.
Exclusion Criteria:
1. A history of >12 ovulation induction cycles without achieving pregnancy.
2. More than three earlier gonadotropin cycles at other clinics or earlier treatments
with threshold doses below 75.
3. Known hyperprolactinaemia or any other endocrine disturbance or systemic disease of
the pituitary gland, thyroid gland, adrenal gland, pancreas, liver or kidney.
4. Undiagnosed vaginal bleeding.
5. Acute or chronic infection with HIV or hepatitis.
6. Persistent ovarian cysts or endometriomas detected by ultrasound.
7. Tumors of the hypothalamus, pituitary gland, breast, adrenal gland or ovary.
8. Pregnancy or lactation.
9. Current or past alcohol or drug abuse.
10. A history of chemo- or radiotherapy.
11. Malformations of reproductive organs incompatible with pregnancy.
12. Hypersensitivity to any trial medication.
Age minimum:
18 Years
Age maximum:
39 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Anovulation
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Infertility
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Intervention(s)
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Drug: Menopur
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Primary Outcome(s)
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The proportion of patients who reach the criteria for hCG-administration within 14 days of FSH stimulation.
[Time Frame: 14 days of FSH stimulation]
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Secondary Outcome(s)
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Endocrinological characteristics and follicular dynamics of anovulatory infertility WHO Group II
[Time Frame: 35 days]
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Secondary ID(s)
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2010-021459-16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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