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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05455151

Enrollment

115

Registered

2022-07-13

Start date

2018-10-01

Completion date

2021-03-01

Last updated

2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thin Endometrium

Keywords

platelet-rich plasma, infertility, endometrial cells

Brief 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.

Detailed description

The study enrolled 115 patients with thin endometrium (\<7 mm at implantation window) and infertility. The cohort was divided into groups based on the treatment regimen. Group 1 (the control, n=30) underwent conservative therapy. Group 2 (n=42) received intraendometrial injections of autologous PRP instead of the conservative therapy. Group 3 (n=38) received identical injections after conservative therapy. Group 4 (n=5) received injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP. Injections of PRP and endometrial cells suspended in autologous PRP into basal layer of endometrium facilitate the reconstitution by enhancing cell proliferation and angiogenesis.

Interventions

PROCEDUREConservative therapy

Conservative therapy to which the patients were subjected was the effect of an electrical impulse

BIOLOGICALPRP injection

This intervention consisted of injecting platelet-rich plasma (PRP) into the endometrium

BIOLOGICALInjection of PRP after conservative therapy

This intervention consisted of conducting conservative therapy with an electrical impulse and then injecting PRP inside the endometrium

BIOLOGICALInjection of PRP with endometrial cells

This intervention consisted of injecting endometrial cells suspended in prp

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Intervention model description

The patients were divided into 4 groups depending on the substances introduced into the basal layer of the endometrium. Group 1 underwent conservative therapy. Group 2 received intraendometrial injections of autologous PRP instead of the conservative therapy. Group 3 received identical injections after conservative therapy. Group 4 received injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in endometrial thickness after treatment compared with control.	Baseline and 2 month	Ultrasonography measurements of endometrial thickness before and after the therapy and compare the thickness. Endometrial thickness measured in mm.
The Doppler-assisted detection of the uterine spiral arteries	1 month	The number of identified vessels is counted and the percentage of detection frequency is calculated accordingly, adjusted for the McNemar's binomial test. Compare the rates of visualization of the uterine spiral arteries after therapy in all groups of patients.
Study of the effect of therapy on the onset of pregnancy	9 months	Investigation of the rates of clinical pregnancies and live births in all groups. After therapy, the number of clinical pregnancy and the number of live births were calculated.
The content of growth factor in autologous PRP	3 month	Investigation of the content of platelet-derived growth factor-BB (PDGF-BB) and vascular endothelial growth factor (VEGF) in autologous PRP. Relative levels of PDGF-BB and VEGF are normalized to the total protein content.
Phenotyping of cells isolated from endometrial biopsies	3 month	Investigation of cellular composition in endometrial biopsy. The percentage of cells positive for markers of mesenzymal stromal cells, epithelial and endothelial cells, lymphocytes is calculated and the determination of the phenotype of cells in endometrial biopsy.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026