Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)
NCT ID: NCT02915900
Last Updated: 2017-09-19
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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COMPLETED
NA
196 participants
INTERVENTIONAL
2014-10-31
2017-07-31
Brief Summary
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Motivated by the lack of standardised procedures to estimate the optimal dosage of gonadotropins, a patient-specific test has been developed to predict the optimal hormone dosage. By measuring internalisation of gonadotropin by the patient's monocytes isolated form the peripheral blood ex vivo, the Gonadotropin Removal Test determines whether a patient needs increased or reduced hormon doses.
In this clinical study the investigators compare deviation from optimal outcome at oocyte pick-up day in two patient groups. Optimal outcome of stimulation is defined as 10 oocytes collected in the group of patients matching the inclusion criteria of the study.
The control group receives starting hormone dosage assigned by the clinician according to standard clinical procedures. The intervention group receives starting hormone dosage adjusted according to the results of the Gonadotropin Removal Test.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention
Hormone dosage is calculated by using the new method Gonadotropin removal test.
Gonadotropin removal test
Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test.
Routine IVF method
Hormone dosage is chosen by the clinician according to standard clinical routine.
Routine IVF method
Patient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician.
Interventions
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Gonadotropin removal test
Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test.
Routine IVF method
Patient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician.
Eligibility Criteria
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Inclusion Criteria
* Pre-selected starting dose \<110 IU or \>270 IU FSH
Exclusion Criteria
* Polycystic ovary syndrome
* Endometriosis stage \>III
* BMI\>33
* Anti-mullerian hormone value missing
18 Years
38 Years
FEMALE
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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Peter Zoltan Fedorcsak
Head of Department
Principal Investigators
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Peter Fedorcsak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
OUS-HF
Locations
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Department of Reproductive Medicine, Oslo University Hospital
Oslo, , Norway
Countries
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Related Links
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Other Identifiers
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233978
Identifier Type: -
Identifier Source: org_study_id