Validation test (“ReceptIVFity-test”) to predict the chance of pregnancy with IVF or IVF-ICSI treatment based on bacteria composition

Analysis of the microbiome to determine the predictive accuracy of the urogenital microbiome for IVF/IVF-ICSI outcome prediction in IVF/IVF-ICSI patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN83157250

Enrollment

300

Registered

2018-08-30

Start date

2015-06-02

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In vitro fertilisation (IVF) and intracytoplasmic sperm injection (IVF-ICSI) Pregnancy and Childbirth In vitro fertilisation (IVF) and intracytoplasmic sperm injection (IVF-ICSI)

Interventions

A microbiome profiling intervention based on a urinary sample and a vaginal swab obtained prior to the start of the IVF or IVF/ICSI treatment. The ultimate goal will be to develop a predictive algorit

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female 2. Indication for an IVF or IVF-ICSI procedure 3. Aged 20-44 years 4. Willing to provide a urine sample and a vaginal swab 5. Willing to provide informed consent 6. Male partner

Exclusion criteria

Exclusion criteria: 1. No transferable embryos after IVF or IVF-ICSI 2. Indication for emergency IVF because of cancer or other reasons 3. AFS (American Fertility Society) III/IV classified endometriosis and pre-treatment with a GnRH (gonadotropin-releasing hormone) analogue 4. >3 weeks use of hormonal contraceptives 3 months prior to start IVF or IVF-ICSI 5. Pregnant previously to the start of the IVF or IVF-ICSI (including miscarriage) 6. Hormonal treatments 3 months prior to start IVF or IVF-ICSI 7. Use of sperm donation

Design outcomes

Primary

Measure	Time frame
To assess the specificity and sensitivity of the urinary and vaginal microbiome composition for the prediction of embryo implantation failure of a consecutive IVF or IVF-ICSI procedure. 1. The composition of the urinary and vaginal samples, assessed by Next Generation Sequencing and the IS-pro technique within the 2 months prior to the embryo transfer 2. Ongoing pregnancy (defined as an intrauterine embryo/foetus with detection of cardiac activity on transvaginal ultrasound between 7-9 weeks of gestation after fresh embryo transfer) 3. Sensitivity - the proportion of women who become pregnant who test mid or high chance to become pregnant based on microbiome analysis using urinary and vaginal samples (true positive (TP) / (TP + false negative (FN))) 4. Specificity - the proportion of women who do not become pregnant who test low chance to become pregnant based on microbiome analysis using urinary and vaginal samples (true negative (TN) / (TN + false positive (FP)))	—

Measure

Time frame

To assess the specificity and sensitivity of the urinary and vaginal microbiome composition for the prediction of embryo implantation failure of a consecutive IVF or IVF-ICSI procedure. 1. The composition of the urinary and vaginal samples, assessed by Next Generation Sequencing and the IS-pro technique within the 2 months prior to the embryo transfer 2. Ongoing pregnancy (defined as an intrauterine embryo/foetus with detection of cardiac activity on transvaginal ultrasound between 7-9 weeks of gestation after fresh embryo transfer) 3. Sensitivity - the proportion of women who become pregnant who test mid or high chance to become pregnant based on microbiome analysis using urinary and vaginal samples (true positive (TP) / (TP + false negative (FN))) 4. Specificity - the proportion of women who do not become pregnant who test low chance to become pregnant based on microbiome analysis using urinary and vaginal samples (true negative (TN) / (TN + false positive (FP)))

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026