IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial.
NCT ID: NCT01992731
Last Updated: 2015-03-27
Study Results
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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UNKNOWN
PHASE4
138 participants
INTERVENTIONAL
2014-12-31
2017-03-31
Brief Summary
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Detailed Description
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Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. .
Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD).
vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IUI group
Group 1: Patients undergo a standard treatment with 3 consecutive gonadotrophin stimulated IUI cycles Intervention: treatment choice and drug:(Follitropine Bèta, Puregon, MSD).
vs.
Drug: Follitropine Bèta
IVF/ICSI arm
Group 2: 1 Patients start immediately with IVF/ICSI instead of IUI. A standard antagonist protocol with treatment with a recombinant FSH (Follitropine Bèta, Puregon, MSD) is used.
Intervention: treatment choice and drug: recombinant FSH (Follitropine Bèta, Puregon,
Drug: Follitropine Bèta
Interventions
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Drug: Follitropine Bèta
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Major uterine or ovarian abnormalities
* Metabolic abnormalities
38 Years
42 Years
FEMALE
Yes
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Michael De Brucker
MD
Principal Investigators
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Michael De Brucker, MD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Locations
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UniversitairZB
Jette, , Belgium
Countries
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Facility Contacts
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Role: backup
Other Identifiers
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IUI versus IVF/ICSI
Identifier Type: -
Identifier Source: org_study_id
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