EUCTR2012-005571-14-ES
Active, not recruiting
Phase 1
CLINICAL TRIAL, SINGLE BLIND, RANDOMIZED, CONTROLLED PROSPECTIVE EVALUATION FOR OPTIMUM TIME INTERVAL BETWEEN ACETATE ADMINISTRATION AND PUNCTURE TRIPTORELIN FOLLICULAR IN IVF TREATMENT
INSTITUTO DE INVESTIGACION SANITARIA LA FE0 sites176 target enrollmentJune 25, 2013
ConditionsINFERTILITYTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
DrugsDECAPEPTYL
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- INFERTILITY
- Sponsor
- INSTITUTO DE INVESTIGACION SANITARIA LA FE
- Enrollment
- 176
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age less than or equal to 37 years. Sterility of tubal origin, unknown or treatable
- •male factor IVF / ICSI using ejaculated semen (including frozen semen donor).
- •Blood levels of basal FSH \<10 mIU / ml on day 3 of the menstrual cycle. Serum
- •AMH\> 5 and \<45 pmol / l Number of antral follicles\> 6 and \<24 between both
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 176
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Diagnosis of endometriosis severe (Grade III\-IV). Diagnosis of SDM. polycystic
- •ovaries (defined according to the Rotterdam criteria). History of low response in
- •ovarian stimulation cycles prior defined as presence of less than 4 follicles greater
- •than 16 mm or canceled cycle. All those patients who do not voluntarily give their
- •express written consent Known allergy to the drug
Outcomes
Primary Outcomes
Not specified
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