Clinical trial NCT06051201: Innovation for Small-scale Experiments: ReceptIVFity Test
Official title: Innovation for Small-scale Experiments: ReceptIVFity Test
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Infertility, Female
Subfertility, Female
Keywords: vaginal microbiome
IVF
IVF/ICSI
pregnancy
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: The Dutch Healthcare Authority
First posted: 2023-09-22
Enrollment: 683
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Rate of Successful pregnancy
timeFrame: 3 years
measure: The number of the successful IVF or IVF/ICSI cycle
timeFrame: 3 years
measure: The total number of IVF or IVF/ICSI treatment cycles per patient.
timeFrame: 3 years
Secondary outcomes:
measure: 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'.
timeFrame: 3 years
measure: The total costs of all received treatments within the study period.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
Other outcomes:
measure: The following patients characteristics will be obtained, such as: age, ethnicity, education level and reproductive history.
timeFrame: 3 years
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: Erasmus MC Rotterdam
name: Sam Schoenmakers, Dr. drs.
role: PRINCIPAL_INVESTIGATOR
References: