Innovation for Small-scale Experiments: ReceptIVFity Test

NCT06051201 | Recruiting

• 1 other identifier: NL75810.078.21
• Study Type: interventional
• Target: 683
• Locations: 1 country
• Sites: 1

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. 1.the success probability of an IVF cycle,
2. 2.the proportion of women with a successful pregnancy
3. 3.the number of unsuccessful IVF cycles.

Conditions

Pregnancy Related; Infertility, Female; Subfertility, Female

Keywords

vaginal microbiome; IVF; IVF/ICSI; pregnancy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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.

  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.

  3 years

Other Outcomes (1)

• The following patients characteristics will be obtained, such as: age, ethnicity, education level and reproductive history.

  3 years

Study Arms (2)

Shared-Decision-Making group

EXPERIMENTAL

Other: ReceptIVFity test (vaginal microbiome swab)

Physician decision group

EXPERIMENTAL

Other: ReceptIVFity test (vaginal microbiome swab)

Interventions

ReceptIVFity test (vaginal microbiome swab) 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; Shared-Decision-Making group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Naïve IVF or IVF/ICSI patients
• Indication for an IVF or IVF-ICSI procedure.
• years \< age \< 43 years.
• Willing to provide a vaginal swab with the ReceptIVFity test.
• Willing to provide informed consent.

You may not qualify if:

• The use of hormonal contraceptives at the time of taking the test.
• The use of antibiotic treatment at the time of taking the test.
• Emergency IVF for cancer or other reasons.
• Women with endometriosis pre-treated with an Gn-RH analogue.
• Women having IVF for egg preservation reasons.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• The Dutch Healthcare Authority: collaborator

Study Sites (1)

Erasmus University Medical Center

Rotterdam, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Sam Schoenmakers, Dr. drs.

  Erasmus MC Rotterdam

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xu Shan Gao, drs.

CONTACT

+31631016348; guvastudie@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: September 22, 2023
• Study Start: September 4, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

NL (1)