Pregnancy RelatedReceptIVFityNCT06051201
Innovation for Small-scale Experiments: ReceptIVFity Test
A study testing ReceptIVFity test (vaginal microbiome swab) in people with Pregnancy Related and Infertility, Female, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Pregnancy Related, Infertility, Female, Subfertility, Female
- What is being tested?
- ReceptIVFity test (vaginal microbiome swab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 683 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Sep 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Center
Rotterdam, 3015GD
Xu Shan Gao, drs., 0031631016348, receptivfitytest@erasmusmc.nl
About this study
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
Read more
- 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.
- Conditions
- Pregnancy Related, Infertility, Female, Subfertility, Female
- Being tested
- ReceptIVFity test (vaginal microbiome swab)
- Keywords
- vaginal microbiome, IVF, IVF/ICSI, pregnancy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Shared-Decision-Making group | Experimental | Not described Receives: Other: ReceptIVFity test (vaginal microbiome swab) |
| Physician decision group | Experimental | Not described Receives: Other: ReceptIVFity test (vaginal microbiome swab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Successful pregnancy
Successful pregnancy (dichotomous) i.e., a pregnancy with a positive heartbeat at 12 weeks of gestation
Measured: 3 years
The number of the successful IVF or IVF/ICSI cycle
The number of the successful IVF or IVF/ICSI cycle
Measured: 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.
Measured: 3 years
Secondary outcomes (3)
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'.
Measured: 3 years
The total costs of all received treatments within the study period.
The total costs of all received treatments within the study period.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start4 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 683 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Dutch Healthcare Authority
- Responsible party
- Principal investigator, Sam Schoenmakers, Erasmus Medical Center
- Investigators
- Sam Schoenmakers, Dr. drs., Principal investigator, Erasmus MC Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051201
- Sponsor's protocol ID
- NL75810.078.21
- Acronym
- ReceptIVFity
- Status last verified
- Sep 2024
- First submitted
- 4 Jul 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovation for Small-scale Experiments: ReceptIVFity Test
- ClinicalTrials.gov ID
- NCT06051201
- Acronym / sponsor ID
- ReceptIVFity / NL75810.078.21
- Conditions
- Pregnancy Related, Infertility, Female, Subfertility, Female
- Keywords
- vaginal microbiome, IVF, IVF/ICSI, pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 683 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- The Dutch Healthcare Authority
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared-Decision-Making group | Experimental | Other: ReceptIVFity test (vaginal microbiome swab) |
| Physician decision group | Experimental | Other: ReceptIVFity test (vaginal microbiome swab) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Physician decision group, Shared-Decision-Making group |
Primary outcome
Rate of Successful pregnancy
Time frame: 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
Time frame: 3 years
The number of the successful IVF or IVF/ICSI cycle
The total number of IVF or IVF/ICSI treatment cycles per patient.
Time frame: 3 years
The total number of IVF or IVF/ICSI treatment cycles per patient.
3 secondary outcomes
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'.
Time frame: 3 years
The total costs of all received treatments within the study period.
Time frame: 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.
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sam Schoenmakers, Dr. drs. principal investigator
Erasmus MC Rotterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReceptIVFity test (vaginal microbiome swab) in people with Pregnancy Related and Infertility, Female, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu Shan Gao, drs. (+31631016348, guvastudie@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Successful pregnancy (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.