NCT03166189

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

1.2 years

First QC Date

May 23, 2017

Last Update Submit

December 31, 2019

Conditions

Infertility, FemaleInfertility of Uterine OriginAsherman Syndrome

Keywords

Repeated IVF failureStem cell

Outcome Measures

Primary Outcomes (1)

  • 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

    3-6 month after randomization

Secondary Outcomes (2)

  • Clinical pregnancy rate

    3-4 weeks after embryo transfer

  • Treatment-Emergent Adverse Events

    3-6 month after randomization

Study Arms (2)

bone marrow-derived MSC and HRT

EXPERIMENTAL

endometrial injection of autologous cell product of MSC with hormonal replacement therapy before frozen/thawed ET

Biological: bone marrow-derived MSC and HRT

hormonal replacement therapy

ACTIVE COMPARATOR

standard endometrial preparation for frozen/thawed ET

Other: hormonal replacement therapy

Interventions

bone marrow-derived MSC and HRTBIOLOGICAL

* 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.

bone marrow-derived MSC and HRT
hormonal replacement therapyOTHER

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

hormonal replacement therapy

Eligibility Criteria

Age21 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Repeated IVF attempts with high and good quality embryo transfer in fresh and frozen IVF cycles;
  • Age 20-44 years;
  • Endometrial thickness less than 6 mm in 2 or more of HRT cycles for endometrial preparation for embryo transfer
  • Hysteroscopic evidence of fibrosis processes of uterine cavity with the absence of positive dynamics of HRT in 3 months following operation;
  • Signed informed consent.

You may not qualify if:

  • Contraindication for pregnancy;
  • Absence of cryopreserved embryos, stored at clinic's cryobank;
  • BMI \> 30 kg/m2;
  • Impaired carbohydrate metabolism according to glucose tolerance test;
  • Thrombosis in anamnesis;
  • Oncological diseases in anamnesis;
  • Diagnosed inherited thrombophilia;
  • Uterine fibroids of more than 4 cm or more than 2 fibroids of 2.5 cm diameter;
  • Nodal form of adenomiosis;
  • Ovarian cysts more than 4 cm in diameter.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Saint Petersburg, 199034, Russia

Location

MeSH Terms

Conditions

Infertility, FemaleGynatresia

Interventions

Hormone Replacement Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Alexandr Gzgzyan, Prof, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Medical Doctor of Assisted Reproduction Technologies department

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 25, 2017

Study Start

December 20, 2017

Primary Completion

March 16, 2019

Study Completion

December 28, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)