NCT03166189

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

Open Randomized Trial of Clinical Efficiency and Safety of Cell Product of Autologous Bone Marrow-derived Mesenchymal Stem Cells for Reparative Treatment of Destructively Changed Endometrium in Patients With Repeated IVF Failures

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology · Academic / Other
• Sex: Female
• Age: 21 Years – 44 Years
• Healthy volunteers: Not accepted

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

Detailed description

Sixty patients eligible for the study will be divided to two groups (experimental and control) according to randomization (envelope) procedure in 1:1 ratio. For patients of the main group bone marrow stem cells will be extracted from the crest of the ilium using standard methodology. After extraction and cultivation final product of autologous bone marrow-derived mesenchymal stem cells will be transplanted to endometrial cavity on menstrual cycle day 5-6. Meanwhile patients will receive three cycles of hormonal replacement therapy (4 mg Progynova (Bayer Pharma, Germany) daily on menstrual cycle day 5-25 in combination with 20 mg Duphaston (Abbott Healthcare Products, B.V., Netherlands) daily from day 15 to day 25. On day 20 of hormonal replacement therapy (HRT) of the last (third) cycle Pipelle-biopsy of endometrium will be performed. Obtained material will be analyzed by immunohistochemistry with the assessment of estrogen and progesterone receptors, VEGFa, GM-CSF, CD133+, CD34 and CD56. Ultrasound characteristics of endometrial quality will be registered on day 9-10 and day 19-21 of every cycle. When morphological and echographic parameters of endometrium are found satisfactory for embryo transfer, the HRT for endometrial preparation for frozen/thawed embryo transfer cycle will be initiated. If acceptable endometrial characteristics are not achieved, patients could be offered to undergo repeated (not more than 3) transplantation of MSC procedures. Control group will receive three standard cycles of HRT following hysteroscopy before frozen/thawed embryo transfer. If endometrial characteristics are found unsatisfactory, gestational surrogacy might be offered.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-20
• Primary completion: 2019-03-16
• Completion: 2019-12-28
• First posted: 2017-05-25
• Last updated: 2020-01-02

Locations

1 site across 1 country: Russia