An interventional study of Seedchrony in Infertility, sponsored by Manina Medtech. Completed at 1 site in Spain. Open to female participants aged 18 Years to 37 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Manina Medtech · Not applicable, Interventional, and Other
In Vitro Fertilization (IVF) success is below 40%, with Embryo Transfer the leading cause of IVF failure. This clinical investigation aims to evaluate if the levels of an intrauterine biomarker dissolved in the uterine fluid (alone or as a complex biological marker) can predict the outcome of embryo transfer.
Seedchorny02 is an exploratory study, with blind evaluation by third parties, in a single center and without influencing clinical practice. The goal of this investigation is to evaluate if the levels of an intrauterine biomarker that is dissolved in the endometrial fluid can predict the outcome of embryo transfer, when measured the day before or on the day of embryo transfer.
80 IVF volunteers in a frozen embryo transfer cycle with high-quality day-five blastocysts are expected to be recruited. For intrauterine measurement, the investigational device Seedchrony RUO 02 will be used. Seedchorny RUO 02 has a microsensor integrated into the transfer catheter to measure the biomarker level in the uterine fluid entering the transfer catheter. Other patients' clinical variables and IVF cycle parameters (hormonal levels, ultrasound parameters, embryo quality grades, and transfer protocol) will also be collected.
Primary variable: Relationship between intrauterine dissolved biomarker concentration (alone or as a complex biological marker) and the outcome of the embryo transfer.
Notes: The intrauterine biomarker concentration is measured twice: the day before the transfer and on the transfer day. Complex biological marker refers to combining the concentration of the biomarker on both days and/or with other clinical variables of the patient/embryo.
The outcome of the embryo transfer is evaluated as:
Chemical pregnancy: positive pregnancy test (blood hGC detection); Clinical pregnancy confirmed by ultrasound at week six (detected gestational sac); Ongoing pregnancy at week eight, confirmed by ultrasound at week eight (detected gestational sac and heartbeat).
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 92 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →This is the only study on the registry with Manina Medtech as lead sponsor.
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Exclusion Criteria:
Intrauterine biomarker will be measured twice in all enrolled patients during the frozen embryo transfer cycle: on the day before embryo transfer and on the day of embryo transfer.
Device: Seedchrony
The seedchrony probe is coupled to the transfer catheter. When the transfer catheter is placed inside the uterus, the probe measures the biomarker concentraction in the fluid entering the catheter. The measurements last two minutes.
Intrauterine biomarker concentration on the day before embryo transfer
The Seedchrony probe is coupled to the transfer catheter and placed in the uterine cavity. The probe measures the biomarker concentration in the fluid entering the catheter.
Time frame: one day
Intrauterine biomarker concentration on the embryo transfer day
The Seedchrony probe is coupled to the transfer catheter and placed in the uterine cavity. The probe measures the biomarker concentration in the fluid entering the catheter.
Time frame: one day
Biochemical Pregnancy
Biochemical Pregnancy outcome will be measured using a serum pregnancy test at 10-14 days after embryo transfer. Results will be record as positive or negative.
Time frame: 10-14 days after embryo transfer
Clinical Pregnancy
Clinical Pregnancy outcome will be assessed by ultrasound at post-transfer week 4. Results will be record as positive or negative.
Time frame: 4 weeks after embryo transfer
Ongoing Pregnancy
Ongoing Pregnancy outcome will be assessed by ultrasound at post-transfer week 6. Results will be record as positive or negative.
Time frame: 6 weeks after embryo transfer
User experience and device safety in the clinical environment
End-user experience and feedback with clinicians' satisfaction questionnaire. Report of events regarding incorrect device handling, dropping, sensor breakage, erroneous readings, and device and software failures.
Time frame: 12 months
Evaluate the patient's experience during measurements.
Visual Analog Scale (VAS) will be used to measure patients' pain and discomfort during measurements. Patients will be asked to rate their experience by making a mark along a line from 1 "no pain" to 10 "worst imaginable pain or discomfort". The distance from the starting point to the mark provides a quantitative measurement of the patient's experience.
Time frame: two days (day before embryo transfer and on the transfer day)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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