Status:
COMPLETED
Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome
Lead Sponsor:
Instituto Valenciano de Infertilidad, IVI VALENCIA
Conditions:
Ovarian Hyperstimulation Syndrome
Eligibility:
FEMALE
21-34 years
Phase:
PHASE2
Brief Summary
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 Objectives Estim...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00665041
Start Date
May 1 2008
End Date
October 1 2008
Last Update
September 17 2009
Active Locations (1)
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1
Instituto Valenciano de Infertilidad
Valencia, Spain, 46015