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NCT Number: NCT05455151

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

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.

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Key information

Conditions

Thin Endometrium Genital Diseases Infertility Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

Moscow, 117997, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conservative therapy

Procedure

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

PRP injection

Biological

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

Injection of PRP after conservative therapy

Biological

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

Injection of PRP with endometrial cells

Biological

This intervention consisted of injecting endometrial cells suspended in prp

Primary outcomes

  1. Change in endometrial thickness after treatment compared with control.

    Time frame: Baseline and 2 month

    Ultrasonography measurements of endometrial thickness before and after the therapy and compare the thickness. Endometrial thickness measured in mm.

  2. The Doppler-assisted detection of the uterine spiral arteries

    Time frame: 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.

  3. Study of the effect of therapy on the onset of pregnancy

    Time frame: 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.

  4. The content of growth factor in autologous PRP

    Time frame: 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.

  5. Phenotyping of cells isolated from endometrial biopsies

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other Gov

Collaborators

  • Sechenov University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2022
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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