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

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT00665041
First received: April 18, 2008
Last updated: September 16, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Ovarian Hyperstimulation Syndrome
Drug: Quinagolide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel Groups, Placebo-controlled, Single-centre Pilot Study Assessing the Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • 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 [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2008
Study Completion Date: October 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PR1 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.

Placebo Comparator: PL1 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.


  Eligibility

Ages Eligible for Study:   21 Years to 34 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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
  21. Hypersensitivity to the active substance or to any of the excipients
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00665041

Locations
Spain
Instituto Valenciano de Infertilidad
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
  More Information

No publications provided

Responsible Party: Dr Antonio Pellicer, Instituto Valenciano de Infertilidad
ClinicalTrials.gov Identifier: NCT00665041     History of Changes
Obsolete Identifiers: NCT00742651
Other Study ID Numbers: VLC-CB-090108-001
Study First Received: April 18, 2008
Last Updated: September 16, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Quinagolide
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 09, 2014