World Health Organization site
Skip Navigation Links

Main
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.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT01250821
Date of registration: 30/11/2010
Primary sponsor: Rigshospitalet, Denmark
Public title: Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility
Scientific title: Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility
Date of first enrolment: December 2010
Target sample size: 60
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT01250821
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Denmark
Contacts
Name:   Mette P Lauritsen, MD
Address: 
Telephone: +45 35451861
Email: mette.petri.lauritsen@rh.regionh.dk
Affiliation: 
Name:   Mette P Lauritsen, MD
Address: 
Telephone: + 45 35451861
Email: mette.petri.lauritsen@rh.regionh.dk
Affiliation: 
Name:   Anders N Andersen, Prof. MD
Address: 
Telephone:
Email:
Affiliation:  Rigshospitalet, Denmark
Name:   Mette P Lauritsen, MD
Address: 
Telephone:
Email:
Affiliation:  Rigshospitalet, Denmark
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Anovulation
Infertility
Intervention(s)
Drug: Menopur
Primary Outcome(s)
The proportion of patients who reach the criteria for hCG-administration within 14 days of FSH stimulation. [Time Frame: 14 days of FSH stimulation]
Secondary Outcome(s)
Endocrinological characteristics and follicular dynamics of anovulatory infertility WHO Group II [Time Frame: 35 days]
Secondary ID(s)
2010-021459-16
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Holbaek Sygehus
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history