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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Infertility, Female; Subfertility, Female
• Intervention / Treatment: Other: ReceptIVFity test (vaginal microbiome swab)

• Study Type: Interventional
• Enrollment (Estimated): 683
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xu Shan Gao, drs.; Phone Number: +31631016348; Email: guvastudie@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015GD
    • Recruiting
    • Erasmus University Medical Center
    • Contact: Xu Shan Gao, drs.; Phone Number: 0031631016348; Email: receptivfitytest@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Successful pregnancy	Successful pregnancy (dichotomous) i.e., a pregnancy with a positive heartbeat at 12 weeks of gestation	3 years
The number of the successful IVF or IVF/ICSI cycle	The number of the successful IVF or IVF/ICSI cycle	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	3 years
The total costs of all received treatments within the study period.	The total costs of all received treatments within the study period.	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.	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The following patients characteristics will be obtained, such as: age, ethnicity, education level and reproductive history.	The following patients characteristics will be obtained, such as: age, ethnicity, education	3 years

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: The Dutch Healthcare Authority
• Investigators: Principal Investigator: Sam Schoenmakers, Dr. drs., Erasmus MC Rotterdam

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: IVF; pregnancy; IVF/ICSI; vaginal microbiome
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: NL75810.078.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No