Pacientes con riesgo del Sindrome de Hiperestimulación Ovárica (SHO) MedDRA version: 9.1 Level: LLT Classification code 10033266 Term: Ovarian hyperstimulation syndrome
Conditions
Interventions
Trade Name: Norprolac
Product Name: Norprolac
Pharmaceutical Form: Tablet
INN or Proposed INN: Quinagolide
CAS Number: 87056-78-8
Current Sponsor code: FE999051
Concentration unit: µg microgram(s)
Con
Sponsors
Instituto Valenciano de Infertilidad
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed Informed Consent Form, prior to screening evaluations 2. In good physical and mental health 3. Pre-menopausal females between the ages of 21-34 years (both inclusive) at the time of randomisation 4. Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive) 5. Oocyte donor currently undergoing a controlled ovarian hyperstimulation cycle for assisted reproductive technologies (ART) 6. Antral follicle count = 20 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any exclusion criteria for oocyte donation 2. Known clinically significant systemic disease (e.g., insulin dependent diabetes) 3. Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study 4. Undiagnosed vaginal bleeding 5. Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus 6. Malformations of the sexual organs incompatible with pregnancy 7. Positive pregnancy test prior to start of stimulation 8. Treatment with other dopamine agonists (ATC code N04BC) or dopamine antagonists (ATC code N05A) within 2 months prior to randomisation 9. Treatment with any hormonal therapy (except for thyroid medication and oral contraceptives and except that routinely used as part of the controlled ovarian hyperstimulation cycle), anti-psychotics (ATC code N05A), anti-depressants (ATC code N06), anxiolytics (ATC code N05B), hypnotics and sedatives (ATC code N05C) or continuous use of prostaglandin inhibitors (non-steroid anti-inflammatory drugs (NSAIDs), including aspirin) within 2 weeks prior to randomisation 10. Known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 11. Known history of psychotic disorders 12. Hypotension, orthostatic hypotension or recurrent syncope within 6 months prior to randomisation 13. Ongoing treatment of hypertension 14. Known previous poor tolerability to dopamine agonists 15. Known impaired hepatic or renal function 16. Current or past (12 months prior to randomisation) abuse of alcohol or drugs, and/or current (last month prior to randomisation) use of alcohol (more than 14 units per week) 17. Current or past (3 months prior to randomisation) smoking habit of more than 20 cigarettes per day 18. History of chemotherapy (except for gestational conditions) or radiotherapy 19. Use of any investigational drug during 3 months prior to randomisation 20. Previous participation in the study Hypersensitivity to the active substance or to any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerability of quinagolide 200 µg/day in a dose-titration regimen in oocyte donors undergoing controlled ovarian hyperstimulation and at risk of developing OHSS;Secondary Objective: To estimate the effects of a quinagolide dose-titration regimen compared to placebo in peritoneal fluid accumulation, incidence of ascites, OHSS symptoms and clinical laboratory parameters of haemoconcentration ;Primary end point(s): Primary Endpoint • Discontinuations from the study because of adverse events related to poor tolerability and overall adverse event profile | — |
Countries
Spain
Outcome results
None listed