Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide

A Randomised, Double-blind, Parallel Groups, Dose-finding, Placebo-controlled, Multi-centre, Proof of Concept Study Assessing the Effect of 3-wk Treatment With 1 of 3 Oral Doses of Quinagolide & Placebo in Preventing Ovarian Hyperstimulation Syndrome in Women Undergoing Controlled Ovarian Hyperstimulation.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00329693

Enrollment

182

Registered

2006-05-25

Start date

2006-06-30

Completion date

2008-05-31

Last updated

2011-05-19

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

Women included in this study are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.

Detailed description

No data to be entered.

Interventions

DRUGNorprolac

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 37 Years

Healthy volunteers

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 21-37 years (both inclusive) at the time of randomisation 4. Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility

Exclusion criteria

1. Any clinically significant systemic disease 2. Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) 3. History of recurrent miscarriage 4. Undiagnosed vaginal bleeding

Design outcomes

Primary

Measure	Time frame
OHSS	41 days after hCG injection

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026