Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)
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|ClinicalTrials.gov Identifier: NCT02915900|
Recruitment Status : Completed
First Posted : September 27, 2016
Last Update Posted : September 19, 2017
During in vitro fertilisation (IVF) treatment, women receive hormone stimulation with gonadotropins to induce growth of several ovarian follicles. Selecting the optimal dosage of gonadotropin is important to avoid maturation of too few or too many follicles, which may impair the chances of treatment success, lead to treatment cancellation, or serious side effects.
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Other: Gonadotropin removal test Other: Routine IVF method||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Method for Determining Optimal FSH Dosage During in Vitro Fertilization (IVF)|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||July 2017|
Hormone dosage is calculated by using the new method Gonadotropin removal test.
Other: Gonadotropin removal test
Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test.
Active Comparator: Routine IVF method
Hormone dosage is chosen by the clinician according to standard clinical routine.
Other: 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.
- Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal follicle aspiration [ Time Frame: The day of follicle aspiration. ]Difference from optimal ovarian response (defined as 10 oocytes collected) is calculated for each patient. The mean these differences is compared between treatment and control groups.
- Consistency of optimal ovarian response during stimulation. [ Time Frame: The day of follicle aspiration. ]Difference from optimal ovarian response (defined as 10 oocytes collected) is calculated for each patient. Variance of these differences is compared between treatment and control groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915900
|Department of Reproductive Medicine, Oslo University Hospital|
|Principal Investigator:||Peter Fedorcsak, MD, PhD||OUS-HF|