A Phase 2 interventional study of bone marrow-derived MSC and HRT and hormonal replacement therapy in Infertility, Female, Infertility of Uterine Origin and Asherman Syndrome, sponsored by D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology. Completed at 1 site in Russian Federation. Open to female participants aged 21 Years to 44 Years. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology · Phase 2, Interventional, and Treatment
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
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 46 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
endometrial injection of autologous cell product of MSC with hormonal replacement therapy before frozen/thawed ET
Biological: bone marrow-derived MSC and HRT
standard endometrial preparation for frozen/thawed ET
Other: hormonal replacement therapy
* 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.
standard treatment of hypoplastic endometrium or Asherman's syndrome: * Three cycles of HRT preceding frozen/thawed embryo transfer; * Frozen/thawed embryo transfer.
Assessment of endometrial receptivity
combination of endometrial thickness on ultrasound and immunohistochemistry of endometrium assessed at the biopsy day of the third cycle of HRT
Time frame: 3-6 month after randomization
Clinical pregnancy rate
presence of intrauterine gestational sac at transvaginal ultrasound at 5-6 weeks of gestation or 5-6 weeks after starting the intervention; measured per frozen/thawed embryo transfer
Time frame: 3-4 weeks after embryo transfer
Treatment-Emergent Adverse Events
Incidence of adverse events: side reactions, abdominal discomfort and patient's tolerance (Safety and Tolerability)
Time frame: 3-6 month after randomization
Plan to share: No
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology