NCT00587327

Brief Summary

The main purpose of this clinical research trial was to evaluate the effects of barusiban and atosiban compared to placebo on luteal phase uterine contractions in oocyte donors supplemented with progesterone.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_2

Geographic Reach
3 countries

5 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

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

December 21, 2007

Last Update Submit

June 20, 2017

Conditions

In Vitro Fertilisation (IVF) Treatment

Outcome Measures

Primary Outcomes (1)

  • Frequency of uterine contractions

    3h after start of dosing

Secondary Outcomes (7)

  • Period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions

    3h after start of dosing

  • Frequency, period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions

    5 min, 15 min, 30 min, 1h, 1h 30 min, 2h, and 2h 30 min after start of dosing

  • Frequency, period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions

    5 min, 30 min, and 1h after mock embryo transfer

  • Frequency, period, external contractile measure, internal contractile measure and total contractile measure of uterine contractions

    30 min and 1h post-dosing and on Day OR +5

  • Inter-subendometrial space

    5 min, 15 min, 30 min, 1h, 1h 30 min, 2h, 2h 30 min, and 3h after start of dosing, at 5 min, 30 min, and 1h after mock embryo transfer, at 30 min and 1h post-dosing and on Day OR +5

  • +2 more secondary outcomes

Study Arms (3)

Barusiban

EXPERIMENTAL
Drug: Barusiban

Atosiban

EXPERIMENTAL
Drug: Atosiban

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BarusibanDRUG

Solution for IV treatment. Bolus and infusion for 4 hours

Barusiban
AtosibanDRUG

Solution for IV administration. Bolus and infusion for 4 hours

Atosiban
PlaceboDRUG

Saline solution for IV administration. Bolus and infusion for 4 hours.

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Participants eligible for this trial were oocyte donors 18-35 years of age, who had undergone controlled ovarian hyperstimulation in the long GnRH agonist protocol or the multiple-dose or single-dose GnRH antagonist protocols, had received hCG (≥ 5,000 IU urinary hCG or 250 μg recombinant hCG) for triggering of final follicular maturation and had undergone oocyte retrieval with a yield of ≥ 6 cumulus-oocyte-complexes. Participants had given signed informed consent, were generally healthy and with a body mass index (BMI) of 18.5-29.9 kg/m2. Participants were excluded in case of endometriosis stage I-IV or uterine pathology. Participants were willing to not have intake of alcoholic beverages during the trial, to not have sexual intercourse during the trial, and to either maintain sexual abstinence or use a highly effective method of contraception from end-of-trial till onset of next menses.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

UZ Brussel, Center for Reproductive Medicine

Brussels, Belgium

Location

Institute for Reproductive Medicine and Endocrinology

Pilsen, 30177, Czechia

Location

ISCARE IVF a.s.

Prague, Czechia

Location

Institut Universitari Dexeus

Barcelona, 08028, Spain

Location

IVI Madrid

Madrid, 28035, Spain

Location

MeSH Terms

Interventions

barusibanatosiban

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

November 1, 2007

Primary Completion

May 1, 2008

Study Completion

September 1, 2008

Last Updated

June 21, 2017

Record last verified: 2017-06

Locations

BE(1)ES(2)CZ(2)