Innovation for Small-scale Experiments: ReceptIVFity Test

NCT ID: NCT06051201

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 683 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-04
• Study Completion Date: 2027-09-30

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.

Conditions

Pregnancy Related; Infertility, Female; Subfertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Shared-Decision-Making group

Group Type: EXPERIMENTAL

ReceptIVFity test (vaginal microbiome swab)

Intervention Type: 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

Physician decision group

Group Type: EXPERIMENTAL

ReceptIVFity test (vaginal microbiome swab)

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Dutch Healthcare Authority

UNKNOWN

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sam Schoenmakers

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sam Schoenmakers, Dr. drs.

Role: PRINCIPAL_INVESTIGATOR

Erasmus MC Rotterdam

Locations

Erasmus University Medical Center

Rotterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Xu Shan Gao, drs.

Role: CONTACT

guvastudie@erasmusmc.nl

+31631016348

Facility Contacts

Xu Shan Gao, drs.

Role: primary

receptivfitytest@erasmusmc.nl

0031631016348

Other Identifiers

NL75810.078.21

Identifier Type: -

Identifier Source: org_study_id