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Evaluation of reactogenicity (absence of fever, nausea, bleeding, pain, and signs of allergic reaction) and implantation rate after exosome injection

Evaluation and efficacy of exosomes derived from umbilical cord Wharton's jelly mesenchymal stem cells (exoserum) as intrauterine injection on embryo implantation rate in women with recurrent implantation failure

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210207050279N2
Enrollment
60
Registered
2026-01-05
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Repeated implantation failure. Complication associated with artificial fertilization, unspecified

Interventions

Intervention 1: Intervention group: 48 hours before the transfer of frozen embryos according to the figures regarding the number of injected particles. For SAFATEY work, first particles/unit 1010×1 ex

Sponsors

Iranian academic center for education culture and research
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women with recurrent implantation failure who have not become pregnant after at least three embryo transfer cycles or after transferring at least ten good-quality embryos Age between 20 - 40 Body mass index below 30 kg/m2

Exclusion criteria

Exclusion criteria: Abnormal uterine shape on hysterosalpingography or hysteroscopyChromosomal abnormalities and genetic disorders in parents Uterine abnormality Intrauterine adhesions

Design outcomes

Primary

MeasureTime frame
Evaluation of reactivity (non-reactor) (absence of fever, nausea, bleeding, pain, and signs of allergic reaction) of exosome injection. Timepoint: Before the start of the intervention, two hours, two weeks, 3 months and 6 months after exosome injection. Method of measurement: Clinical evaluation.;Implantation. Timepoint: 4 weeks after embryo transfer. Method of measurement: Vaginal ultrasound.

Secondary

MeasureTime frame
Abortion rate. Timepoint: During pregnancy. Method of measurement: Ultrasound.;Endometrial thickness and quality. Timepoint: 48 hours after injection. Method of measurement: Vaginal ultrasound.;Pregnancy. Timepoint: 4 weeks after embryo transfer. Method of measurement: Vaginal ultrasound.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAtefeh Verdi

Iranian academic center for education culture and research

Atefeh.verdi@yahoo.com+98 25 3270 0155

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026