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

Primary Purpose

Ovarian Hyperstimulation Syndrome

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Quinagolide
Sponsored by
Instituto Valenciano de Infertilidad, IVI VALENCIA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Hyperstimulation Syndrome

Eligibility Criteria

21 Years - 34 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto Valenciano de Infertilidad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PR1

PL1

Arm Description

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
April 18, 2008
Last Updated
September 16, 2009
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
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1. Study Identification

Unique Protocol Identification Number
NCT00665041
Brief Title
Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PR1
Arm Type
Experimental
Arm Title
PL1
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Quinagolide
Intervention Description
• 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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto Valenciano de Infertilidad
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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