Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome

Inclusion criteria

• Signed Informed Consent Form, prior to screening evaluations
• In good physical and mental health
• Pre-menopausal females between the ages of 21-34 years (both inclusive) at the time of randomisation
• Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive)
• Oocyte donor currently undergoing a controlled ovarian hyperstimulation cycle for assisted reproductive technologies (ART)
• Antral follicle count ≥ 20

Exclusion criteria

• Any exclusion criteria for oocyte donation
• Known clinically significant systemic disease (e.g., insulin dependent diabetes)
• Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study
• Undiagnosed vaginal bleeding
• Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
• Malformations of the sexual organs incompatible with pregnancy
• Positive pregnancy test prior to start of stimulation
• Treatment with other dopamine agonists (ATC code N04BC) or dopamine antagonists (ATC code N05A) within 2 months prior to randomisation
• 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
• Known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• Known history of psychotic disorders
• Hypotension, orthostatic hypotension or recurrent syncope within 6 months prior to randomisation
• Ongoing treatment of hypertension
• Known previous poor tolerability to dopamine agonists
• Known impaired hepatic or renal function
• 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)
• Current or past (3 months prior to randomisation) smoking habit of more than 20 cigarettes per day
• History of chemotherapy (except for gestational conditions) or radiotherapy
• Use of any investigational drug during 3 months prior to randomisation
• Previous participation in the study
• Hypersensitivity to the active substance or to any of the excipients