Infertility
Conditions
Keywords
In vitro fertilization
Brief summary
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.
Interventions
OTHERGonadotropin removal test
Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test.
OTHERRoutine IVF method
Patient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician.
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* Stimulation according to the mid-luteal phase gonadotropin-releasing hormone-agonist protocol * Pre-selected starting dose \<110 IU or \>270 IU FSH
Exclusion criteria
* Risk for hyperstimulation * Polycystic ovary syndrome * Endometriosis stage \>III * BMI\>33 * Anti-mullerian hormone value missing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deviation from optimal ovarian response, defined as 10 oocytes collected during transvaginal follicle aspiration | 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. | 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. |
Countries
Norway
Outcome results
None listed