CompletedPhase 1

Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium

Russia115 participantsStarted 2018-10-01

Plain-language summary

The investigation is devoted to the study of the effect of the introduction of autologous platelet-rich plasma (PRP) on the thickness of the endometrium. It was found that the injection of PRP and endometrial cells resuspended in PRP into the endometrium of patients with thin endometrium leads to an increase in the proliferation of endometrial cells, and as a result, to an increase in its thickness.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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: * Age 18-40 years * Normal karyotype * Normal karyotype of the partner * Regular ovulatory and menstrual cycle * Endometrium \<7 mm thick as measured at implantation window * Availability of ≥2 vitrified blastocysts of good quality * History of implantation failure and/or embryo transfer (ET) cancellation due to insufficient endometrial thickness Exclusion Criteria: * Pathospermia in partner * Use of donor gametes * Premature ovarian failure * Internal genital anomalies * Systemic blood diseases and coagulopathy * Hemoglobin \<100 g/L * Platelets \<100×109/L * Antiplatelet/anticoagulant therapy recipient status

What they're measuring

Change in endometrial thickness after treatment compared with control.

Timeframe: Baseline and 2 month

The Doppler-assisted detection of the uterine spiral arteries

Timeframe: 1 month

Study of the effect of therapy on the onset of pregnancy

Timeframe: 9 months

The content of growth factor in autologous PRP

Timeframe: 3 month

Phenotyping of cells isolated from endometrial biopsies

Timeframe: 3 month

Trial details

NCT IDNCT05455151

SponsorFederal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2021-01-11

View on ClinicalTrials.gov More Thin Endometrium trials

Plain-language summary

Who can participate

Age range18 Years – 40 Years

SexFEMALE

See this in plain English?

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

What they're measuring

Change in endometrial thickness after treatment compared with control.

Timeframe: Baseline and 2 month

The Doppler-assisted detection of the uterine spiral arteries

Timeframe: 1 month

Study of the effect of therapy on the onset of pregnancy

Timeframe: 9 months

The content of growth factor in autologous PRP

Timeframe: 3 month

Phenotyping of cells isolated from endometrial biopsies

Timeframe: 3 month