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Innovation for Small-scale Experiments: ReceptIVFity Test (ReceptIVFity)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06051201
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
Sponsor:
Collaborator:
The Dutch Healthcare Authority
Information provided by (Responsible Party):
Sam Schoenmakers, Erasmus Medical Center

Study Description
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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

  1. the success probability of an IVF cycle,
  2. the proportion of women with a successful pregnancy
  3. 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
Pregnancy Related Infertility, Female Subfertility, Female Other: ReceptIVFity test (vaginal microbiome swab) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 683 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Innovation for Small-scale Experiments: ReceptIVFity Test
Actual Study Start Date : September 4, 2023
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Rate of Successful pregnancy [ Time Frame: 3 years ]
    Successful pregnancy (dichotomous) i.e., a pregnancy with a positive heartbeat at 12 weeks of gestation

  2. The number of the successful IVF or IVF/ICSI cycle [ Time Frame: 3 years ]
    The number of the successful IVF or IVF/ICSI cycle

  3. 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.


Secondary Outcome Measures :
  1. 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 ]
    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'.

  2. The total costs of all received treatments within the study period. [ Time Frame: 3 years ]
    The total costs of all received treatments within the study period.

  3. 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 ]
    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:
  1. The following patients characteristics will be obtained, such as: age, ethnicity, education level and reproductive history. [ Time Frame: 3 years ]
    The following patients characteristics will be obtained, such as: age, ethnicity, education


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Naïve IVF or IVF/ICSI patients
  2. Indication for an IVF or IVF-ICSI procedure.
  3. 18 years < age < 43 years.
  4. Willing to provide a vaginal swab with the ReceptIVFity test.
  5. Willing to provide informed consent.

Exclusion Criteria:

  1. The use of hormonal contraceptives at the time of taking the test.
  2. The use of antibiotic treatment at the time of taking the test.
  3. Emergency IVF for cancer or other reasons.
  4. Women with endometriosis pre-treated with an Gn-RH analogue.
  5. Women having IVF for egg preservation reasons.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051201


Contacts
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Contact: Xu Shan Gao, drs. +31631016348 guvastudie@erasmusmc.nl

Locations
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Netherlands
Erasmus University Medical Center Recruiting
Rotterdam, Netherlands, 3015GD
Contact: Xu Shan Gao, drs.    0031631016348    receptivfitytest@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center
The Dutch Healthcare Authority
Investigators
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Principal Investigator: Sam Schoenmakers, Dr. drs. Erasmus MC Rotterdam
More Information
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Responsible Party: Sam Schoenmakers, Principal Investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT06051201    
Other Study ID Numbers: NL75810.078.21
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sam Schoenmakers, Erasmus Medical Center:
vaginal microbiome
IVF
IVF/ICSI
pregnancy
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases
Urogenital Diseases
 Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications