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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00665041

Enrollment

Registered

2008-04-23

Start date

2008-05-31

Completion date

2008-10-31

Last updated

2009-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Hyperstimulation Syndrome

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

Interventions

DRUGQuinagolide

• 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 34 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026