Optimising FSH Dosage During in Vitro Fertilization Fertilization (IVF)

Study Overview
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Brief Summary
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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.

Official Title
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Method for Determining Optimal FSH Dosage During in Vitro Fertilization (IVF)

Conditions
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Infertility

Intervention / Treatment
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* Other: Gonadotropin removal test
* Other: Routine IVF method


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Hormone dosage is calculated by using the new method Gonadotropin removal test. | Other: Gonadotropin removal test<br>* Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test.<br>|
| Active Comparator: Routine IVF method<br>Hormone dosage is chosen by the clinician according to standard clinical routine. | Other: Routine IVF method<br>* Patient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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In vitro fertilization