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A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.

NCT ID: NCT00708539

Last Updated: 2008-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

2686 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-12-31

Brief Summary

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To compare the effect of Crinone 8% administered once daily versus other vaginal progesterone in terms of ongoing pregnancy rate 5 weeks after embryo transfer as well as patient convenience.

Detailed Description

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Conditions

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IVF - Luteal Phase Support After Embryo Transfer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Crinone vaginal gel 8% 90 mg once daily

Group Type ACTIVE_COMPARATOR

progesterone

Intervention Type DRUG

90 mg, vaginal, once daily

2

Progesterone mic 400 mg three times daily

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

200 mg, vaginal, three times daily used in Denmark, 400 mg, vaginal, three times daily used in Sweden

Interventions

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progesterone

90 mg, vaginal, once daily

Intervention Type DRUG

Progesterone

200 mg, vaginal, three times daily used in Denmark, 400 mg, vaginal, three times daily used in Sweden

Intervention Type DRUG

Other Intervention Names

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crinone 8% Progestan in Denmark Progesterone mic in Sweden

Eligibility Criteria

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Inclusion Criteria

* 18-40 years
* Regular menstrual cyclus 25-35 days
* both ovaries present
* No more than 2 previous IVF attempts
* Have given written informed consent

Exclusion Criteria

* More than 2 previous attempts
* Known drug abuse
* Known allergies to the study medication
* No embryo transfer performed in the study cycle
* Previous participating in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono International SA

INDUSTRY

Sponsor Role collaborator

Nordica Fertility Clinic

OTHER

Sponsor Role lead

Responsible Party

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Nordica fertility clinic

Principal Investigators

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Svend Lindenberg

Role: PRINCIPAL_INVESTIGATOR

Nordica Fertilityclinic

Svend Lindenberg

Role: PRINCIPAL_INVESTIGATOR

Nordica Fertility Clinic

Locations

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Faurskov fertility clinic

Aalborg, , Denmark

Site Status TERMINATED

Brædstrup Sygehus

Brædstrup, , Denmark

Site Status RECRUITING

Dronninglund sygehus

Dronninglund, , Denmark

Site Status RECRUITING

Dansk Fertilitetsklinik

Frederiksberg, , Denmark

Site Status RECRUITING

Herlev Hospital

Herlev, , Denmark

Site Status RECRUITING

Holbæk Sygehus

Holbæk, , Denmark

Site Status RECRUITING

Hvidovre Hospital

Hvidovre, , Denmark

Site Status RECRUITING

Rigshospitalet

København Ø, , Denmark

Site Status RECRUITING

Odense IVF

Odense, , Denmark

Site Status RECRUITING

Odense OUH

Odense, , Denmark

Site Status RECRUITING

Roskilde Sygehus

Roskilde, , Denmark

Site Status RECRUITING

Skive sygehus

Skive, , Denmark

Site Status RECRUITING

Reproduktionscentrum, Sahlgrenska

Gothenburg, , Sweden

Site Status RECRUITING

Karolinska

Huddinge, , Sweden

Site Status RECRUITING

RMC

Malmo, , Sweden

Site Status RECRUITING

Reproduktionscentrum

Stockholm, , Sweden

Site Status RECRUITING

Norrlandsuniversitets sjukhus

Umeå, , Sweden

Site Status RECRUITING

Countries

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Denmark Sweden

Central Contacts

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Svend Lindenberg

Role: CONTACT

Phone: 004533257000

Email: [email protected]

Facility Contacts

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Finn Hald

Role: primary

Michael Aasted

Role: primary

Hans Krogh

Role: primary

Jan Blaabjerg

Role: primary

Helle E Bredkær

Role: primary

Helle Meinertz

Role: primary

Anders N Andersen

Role: primary

Sven Rex

Role: primary

Lars Westergaard

Role: primary

Anette Lindhard

Role: primary

Peter Humaidan

Role: primary

Other Identifiers

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Eudra CT nr.2005-001248-22

Identifier Type: -

Identifier Source: secondary_id

25921

Identifier Type: -

Identifier Source: org_study_id