Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome
NCT00665041 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2009-09-17
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
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
Conditions
- Ovarian Hyperstimulation Syndrome
Interventions
- DRUG
-
Quinagolide
• Quinagolide 200 μg/day (dose titration from 50 μg/day to 100 μg/day to 200 μg/day), oral. Quinagolida tablets, 50 mcg. placebo, oral.
Sponsors & Collaborators
-
Instituto Valenciano de Infertilidad, IVI VALENCIA
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 34 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2008-08-31
- Completion
- 2008-10-31
Countries
- Spain
Study Locations
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