Innovation for Small-scale Experiments: ReceptIVFity Test
Study Details
Study Description
Brief Summary
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
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the success probability of an IVF cycle,
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the proportion of women with a successful pregnancy
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Shared-Decision-Making group
|
Other: ReceptIVFity test (vaginal microbiome swab)
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
|
| Experimental: Physician decision group
|
Other: ReceptIVFity test (vaginal microbiome swab)
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
|
Outcome Measures
Primary Outcome Measures
- Rate of Successful pregnancy [3 years]
Successful pregnancy (dichotomous) i.e., a pregnancy with a positive heartbeat at 12 weeks of gestation
- The number of the successful IVF or IVF/ICSI cycle [3 years]
The number of the successful IVF or IVF/ICSI cycle
- The total number of IVF or IVF/ICSI treatment cycles per patient. [3 years]
The total number of IVF or IVF/ICSI treatment cycles per patient.
Secondary Outcome Measures
- 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]
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'.
- The total costs of all received treatments within the study period. [3 years]
The total costs of all received treatments within the study period.
- 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]
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.
Other Outcome Measures
- The following patients characteristics will be obtained, such as: age, ethnicity, education level and reproductive history. [3 years]
The following patients characteristics will be obtained, such as: age, ethnicity, education
Eligibility Criteria
Criteria
Inclusion Criteria:
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Naïve IVF or IVF/ICSI patients
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Indication for an IVF or IVF-ICSI procedure.
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18 years < age < 43 years.
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Willing to provide a vaginal swab with the ReceptIVFity test.
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Willing to provide informed consent.
Exclusion Criteria:
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The use of hormonal contraceptives at the time of taking the test.
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The use of antibiotic treatment at the time of taking the test.
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Emergency IVF for cancer or other reasons.
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Women with endometriosis pre-treated with an Gn-RH analogue.
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Women having IVF for egg preservation reasons.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Erasmus University Medical Center | Rotterdam | Netherlands | 3015GD |
Sponsors and Collaborators
- Erasmus Medical Center
- The Dutch Healthcare Authority
Investigators
- Principal Investigator: Sam Schoenmakers, Dr. drs., Erasmus MC Rotterdam
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL75810.078.21