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| Name | Class |
|---|---|
| The Dutch Healthcare Authority | UNKNOWN |
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The ReceptIVFity acts as a timing-tool for prediction of optimal pregnancy chances and provides insight into the patient's current (two months after sampling) success rate of an IVF/IVF-ICSI treatment. Benefits of physician decision treatment in case of an unfavorable vaginal profile and a low chance of achieving a pregnancy include reducing unnecessary morbidity and treatment cycles, stress and disappointment, while increasing efficacy of the treatment and lowering the costs needed to achieve a pregnancy.
The goal of this prospective, clinical non-invasive randomized controlled study, with an additional observational study arm (for women of non-European origin) in naïve IVF or IVF/ICSI patients is to evaluate the efficiency of Shared Decision Making compared to Physician Decision in terms of
Randomization component Women of European origin will be randomized 1:1 to either the shared decision group or the physician decision group. All women of European origin may undergo one to three cycles of IVF/IVF-ICSI reimbursed by the health insurance. The follow-up ends after the outcome of the last of these cycles has been determined. The desired outcome of the IVF or IVF/ICSI treatment is a successful pregnancy, i.e., a pregnancy with a heart-beat at 12 weeks of gestation.
Observational component Women of non-European origin are invited to take part in an observational component of this study. Without further evaluation of the results of their vaginal microbiome, they will continue with the IVF/IVF-ICSI cycle. Women eligible for participation are naïve patients and the follow-up ends after the outcome of the first IVF/IVF-ICSI cycle has been determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared-Decision-Making group | Experimental |
| |
| Physician decision group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReceptIVFity test (vaginal microbiome swab) | Other | A vaginal self-swab for determination of the vaginal microbiome is performed by the patient. For women of European origin randomization in one of the following groups: SDM group: Using Shared-Decision-Making according to the ReceptIVFity microbiome profile with its predicted chance of achieving a pregnancy in the current cycle. Physician decision group: Postponing treatment until a switch to a favorable ReceptIVFity microbiome profile |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Successful pregnancy | Successful pregnancy (dichotomous) i.e., a pregnancy with a positive heartbeat at 12 weeks of gestation | 3 years |
| The number of the successful IVF or IVF/ICSI cycle | The number of the successful IVF or IVF/ICSI cycle | 3 years |
| The total number of IVF or IVF/ICSI treatment cycles per patient. | The total number of IVF or IVF/ICSI treatment cycles per patient. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Scores of the SDM-Q-9 (questionnaire for patient satisfaction), which consists of nine statements that can be rated on a six-point scale from 0= 'completely disagree' to 5= 'completely agree'. | Scores of the SDM-Q-9 (questionnaire for patient satisfaction), which consists of nine statements that can be rated on a six-point scale from 0= 'completely disagree' to 5= 'completely agree'. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The following patients characteristics will be obtained, such as: age, ethnicity, education level and reproductive history. | The following patients characteristics will be obtained, such as: age, ethnicity, education | 3 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xu Shan Gao, drs. | Contact | +31631016348 | guvastudie@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Sam Schoenmakers, Dr. drs. | Erasmus MC Rotterdam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus University Medical Center | Recruiting | Rotterdam | 3015GD | Netherlands |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| The total costs of all received treatments within the study period. | The total costs of all received treatments within the study period. | 3 years |
| Pregnancy at 12 weeks after a first IVF or an IVF-ICSI procedure with an ET in women with non-European origin included in the observational part of this study. | Pregnancy at 12 weeks after a first IVF or an IVF-ICSI procedure with an ET in women with non-European origin included in the observational part of this study. | 3 years |
| D000091662 | Genital Diseases |
| D007246 | Infertility |