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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Hormone dosage is calculated by using the new method Gonadotropin removal test. |
|
| Routine IVF method | Active Comparator | Hormone dosage is chosen by the clinician according to standard clinical routine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gonadotropin removal test | Other | Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal 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. | The day of follicle aspiration. |
| Consistency of optimal ovarian response during stimulation. | 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. | The day of follicle aspiration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Fedorcsak, MD, PhD | OUS-HF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Reproductive Medicine, Oslo University Hospital | Oslo | Norway |
Data might be shared with patient if requested
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Routine IVF method | Other | Patient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician. |
|