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Autologous Bone Marrow-derived Mesenchymal Stem Cells for Atrophic Endometrium in Patients With Repeated IVF Failures

NCT03166189 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-01-02

No results posted yet for this study

Summary

Investigators will examine safety and efficiency of the cell product of autologous bone marrow-derived mesenchymal stem cells (MSC) for patients with repeated IVF failures and hypoplastic or/and fibrosis process of endometrium

Conditions

  • Infertility, Female
  • Infertility of Uterine Origin
  • Asherman Syndrome

Interventions

BIOLOGICAL

bone marrow-derived MSC and HRT

* Transplantation procedure to endometrial cavity is performed with ultrasound guidance on menstrual cycle day 5-6 through uterine cervix using cater for embryo transfer with 1 ml of suspension containing 5 millions of autologous bone marrow-derived mesenchymal stem cells * Three cycles of HRT following MSC transplantation; * Pipelle-biopsy of endometrium on day 20 of hormonal replacement therapy of the last (third) cycle; * Frozen/thawed embryo transfer 3-6 months after transplantation.

OTHER

hormonal replacement therapy

standard treatment of hypoplastic endometrium or Asherman's syndrome: * Three cycles of HRT preceding frozen/thawed embryo transfer; * Frozen/thawed embryo transfer.

Sponsors & Collaborators

  • D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology

    lead OTHER

Principal Investigators

  • Alexandr Gzgzyan, Prof, PhD · D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2019-03-16
Completion
2019-12-28

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03166189 on ClinicalTrials.gov