CompletedPhase 2

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

Russia46 participantsStarted 2017-12-20

Plain-language 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

Who can participate

Age range

21 Years – 44 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of endometrial receptivity

Timeframe: 3-6 month after randomization

Trial details

NCT IDNCT03166189

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-16

View on ClinicalTrials.gov More Infertility, Female trials