Status:
COMPLETED
Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Infertility, Female
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.
Detailed Description
For the primary end-point (data collected on Stimulation Day 1), the study will compare degarelix 2.5 mg administered in the mid-luteal phase to placebo administered in the mid-luteal phase. After St...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Signed Informed Consent Form, prior to screening evaluations
- In good physical and mental health
- Pre-menopausal females between the ages of 18-35 years (both inclusive) at the time of randomisation
- Regular menstrual cycles of 26-35 days duration (both inclusive), presumed to be ovulatory
- Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive)
- Willing to donate the retrieved oocytes
- Willing to use an adequate barrier method of contraception from informed consent to Day hCG injection +7 and to use an adequate barrier or hormonal method of contraception from Day hCG injection +7 to the end-of-study visit
- Exclusion Criteria
- Abnormal karyotype
- Any known clinically significant systemic disease (e.g., insulin dependent diabetes)
- Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study
- Diagnosed with polycystic ovarian syndrome or endometriosis stage III/IV
- Diagnosed as "poor responder"
- History of recurrent miscarriage (defined as three consecutive spontaneous losses before weeks 24 of pregnancy)
- Pregnancy or lactation
- Use of any investigational drug during 3 months prior to start of the current COH cycle
- Previous participation in the study
- Hypersensitivity to any trial product
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT00434122
Start Date
March 1 2007
End Date
December 1 2007
Last Update
June 2 2011
Active Locations (4)
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1
UZ Brussel
Brussels, Belgium
2
ISCARE IVF a.s.
Prague, Czechia
3
IVI-Madrid
Madrid, Spain
4
IVI-Valencia
Valencia, Spain