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

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

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

Study Overview

• Status: Completed
• Conditions: Ovarian Hyperstimulation Syndrome
• Intervention / Treatment: Drug: Quinagolide

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46015
    • Instituto Valenciano de Infertilidad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 32 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	21 days

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 22, 2008
• First Posted (Estimate): April 23, 2008

Study Record Updates

• Last Update Posted (Estimate): September 17, 2009
• Last Update Submitted That Met QC Criteria: September 16, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Disease; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Syndrome; Ovarian Hyperstimulation Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Quinagolide
• Other Study ID Numbers: VLC-CB-090108-001