Innovation for Small-scale Experiments: ReceptIVFity Test

Erasmus University

Status: Enrolling

Conditions: Pregnancy Related; Subfertility, Female; Infertility, Female

Treatments: Other: ReceptIVFity test (vaginal microbiome swab)

Study type: Interventional

Funder types: Other

Identifiers

NCT06051201

NL75810.078.21

Details and patient eligibility

About

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.

Enrollment: 683 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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683 participants in 2 patient groups

Shared-Decision-Making group

Experimental group

Treatment:

Other: ReceptIVFity test (vaginal microbiome swab)

Physician decision group

Experimental group

Treatment:

Other: ReceptIVFity test (vaginal microbiome swab)