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

Ovarian Hyperstimulation Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665041
• Other study ID #: VLC-CB-090108-001
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2008
• Last updated: September 16, 2009
• Start date: May 2008
• Est. completion date: October 2008

Study information

• Verified date: September 2009
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

Other known NCT identifiers

• NCT00742651

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 34 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Infertilidad	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No