NCT00329693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 19, 2011

Status Verified

May 1, 2011

Enrollment Period

1.2 years

First QC Date

May 23, 2006

Last Update Submit

May 18, 2011

Conditions

Ovarian Hyperstimulation Syndrome

Outcome Measures

Primary Outcomes (1)

  • OHSS

    41 days after hCG injection

Study Arms (4)

1

PLACEBO COMPARATOR

Daily Tablets Dosing

Drug: Norprolac

2

EXPERIMENTAL

Daily Tablets Dose

Drug: Norprolac

3

EXPERIMENTAL

Daily Tablets Dosing

Drug: Norprolac

4

EXPERIMENTAL

Daily Tablets Dosing

Drug: Norprolac

Interventions

NorprolacDRUG

Placebo

1

Eligibility Criteria

Age21 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

IVI Barcelona, Ronda General Mitre, 14

Barcelona, 08017, Spain

Location

IVI Bilbao, Paseo Landabarri, 1

Leioa-Bizkaia, 48940, Spain

Location

IVI Madrid, Santiago de Compostela, 88

Madrid, 28035, Spain

Location

IVI Murcia, Navegante Macías del Poyo, 5, Edificio Delfín-Barrio La Flota

Murcia, 30007, Spain

Location

IVI Sevilla, Avda. República Argentina, 58

Seville, 41011, Spain

Location

IVI Valencia, Plaza de la Policía Local, 3

Valencia, 46015, Spain

Location

IVI Vigo, Plaza Francisco Fernández del Riego, 7 (Plaza Elíptica)

Vigo (Pontevedra), 36203, Spain

Location

Related Publications (2)

  • Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.

    PMID: 33851429DERIVED

  • Busso C, Fernandez-Sanchez M, Garcia-Velasco JA, Landeras J, Ballesteros A, Munoz E, Gonzalez S, Simon C, Arce JC, Pellicer A. The non-ergot derived dopamine agonist quinagolide in prevention of early ovarian hyperstimulation syndrome in IVF patients: a randomized, double-blind, placebo-controlled trial. Hum Reprod. 2010 Apr;25(4):995-1004. doi: 10.1093/humrep/deq005. Epub 2010 Feb 6.

    PMID: 20139430DERIVED

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

quinagolide

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 23, 2006

First Posted

May 25, 2006

Study Start

June 1, 2006

Primary Completion

August 1, 2007

Study Completion

May 1, 2008

Last Updated

May 19, 2011

Record last verified: 2011-05

Locations

ES(7)