Innovation for Small-scale Experiments: ReceptIVFity Test (ReceptIVFity)
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ClinicalTrials.gov Identifier: NCT06051201 |
Recruitment Status :
Recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
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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
- the success probability of an IVF cycle,
- the proportion of women with a successful pregnancy
- 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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pregnancy Related Infertility, Female Subfertility, Female | Other: ReceptIVFity test (vaginal microbiome swab) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 683 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Innovation for Small-scale Experiments: ReceptIVFity Test |
Actual Study Start Date : | September 4, 2023 |
Estimated Primary Completion Date : | September 2026 |
Estimated Study Completion Date : | September 2027 |
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 |
- Rate of Successful pregnancy [ Time Frame: 3 years ]Successful pregnancy (dichotomous) i.e., a pregnancy with a positive heartbeat at 12 weeks of gestation
- The number of the successful IVF or IVF/ICSI cycle [ Time Frame: 3 years ]The number of the successful IVF or IVF/ICSI cycle
- The total number of IVF or IVF/ICSI treatment cycles per patient. [ Time Frame: 3 years ]The total number of IVF or IVF/ICSI treatment cycles per patient.
- 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'. [ Time Frame: 3 years ]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'.
- The total costs of all received treatments within the study period. [ Time Frame: 3 years ]The total costs of all received treatments within the study period.
- 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. [ Time Frame: 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.
- The following patients characteristics will be obtained, such as: age, ethnicity, education level and reproductive history. [ Time Frame: 3 years ]The following patients characteristics will be obtained, such as: age, ethnicity, education
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 42 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Naïve IVF or IVF/ICSI patients
- Indication for an IVF or IVF-ICSI procedure.
- 18 years < age < 43 years.
- Willing to provide a vaginal swab with the ReceptIVFity test.
- Willing to provide informed consent.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051201
Contact: Xu Shan Gao, drs. | +31631016348 | guvastudie@erasmusmc.nl |
Netherlands | |
Erasmus University Medical Center | Recruiting |
Rotterdam, Netherlands, 3015GD | |
Contact: Xu Shan Gao, drs. 0031631016348 receptivfitytest@erasmusmc.nl |
Principal Investigator: | Sam Schoenmakers, Dr. drs. | Erasmus MC Rotterdam |
Responsible Party: | Sam Schoenmakers, Principal Investigator, Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT06051201 |
Other Study ID Numbers: |
NL75810.078.21 |
First Posted: | September 22, 2023 Key Record Dates |
Last Update Posted: | September 22, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
vaginal microbiome IVF IVF/ICSI pregnancy |
Infertility Infertility, Female Genital Diseases Urogenital Diseases |
Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |