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

Study Overview
=================
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

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

Conditions
-----------------
Ovarian Hyperstimulation Syndrome

Intervention / Treatment
-----------------
* Drug: Quinagolide


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 34 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PR1<br> | Drug: Quinagolide<br>* • 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.<br>|
| Placebo Comparator: PL1<br> | Drug: Quinagolide<br>* • 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |