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

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.

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Key information

Conditions

Ovarian Hyperstimulation Syndrome Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Age range

21 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

IVI Barcelona, Ronda General Mitre, 14, Barcelona, Spain

About this study

No data to be entered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed Informed Consent Form, prior to screening evaluations
In good physical and mental health
Pre-menopausal females between the ages of 21-37 years (both inclusive) at the time of randomisation
Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility

Exclusion criteria

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

Treatment and study plan

Norprolac

Drug

Placebo

Primary outcomes

OHSS

Time frame: 41 days after hCG injection

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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.

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2008
First posted: May 25, 2006
Registry last updated: May 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed