Innovation for Small-scale Experiments: ReceptIVFity Test

Study Overview
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Brief Summary
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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 the success probability of an IVF cycle, the proportion of women with a successful pregnancy the number of unsuccessful IVF cycles. 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.

Official Title
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Innovation for Small-scale Experiments: ReceptIVFity Test

Conditions
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Pregnancy Related, Infertility, Female, Subfertility, Female

Intervention / Treatment
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* Other: ReceptIVFity test (vaginal microbiome swab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Naïve IVF or IVF/ICSI patients Indication for an IVF or IVF-ICSI procedure. 18 years < age < 43 years. Willing to provide a vaginal swab with the ReceptIVFity test. Willing to provide informed consent. Exclusion Criteria: The use of hormonal contraceptives at the time of taking the test. The use of antibiotic treatment at the time of taking the test. Emergency IVF for cancer or other reasons. Women with endometriosis pre-treated with an Gn-RH analogue. Women having IVF for egg preservation reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared-Decision-Making group<br> | Other: ReceptIVFity test (vaginal microbiome swab)<br>* 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<br>|
| Experimental: Physician decision group<br> | Other: ReceptIVFity test (vaginal microbiome swab)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal microbiome, IVF, IVF/ICSI, pregnancy