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

NCT ID: NCT00665041

Last Updated: 2009-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-10-31

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

Conditions

Ovarian Hyperstimulation Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PR1

Group Type: EXPERIMENTAL

Quinagolide

Intervention Type: DRUG

• 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.

PL1

Group Type: PLACEBO_COMPARATOR

Quinagolide

Intervention Type: DRUG

• 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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role: lead

Responsible Party

Instituto Valenciano de Infertilidad

Locations

Instituto Valenciano de Infertilidad

Valencia, , Spain

Countries

Spain

Other Identifiers

VLC-CB-090108-001

Identifier Type: -

Identifier Source: org_study_id

NCT00742651

Identifier Type: -

Identifier Source: nct_alias