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

NCT05455151 | Completed Phase 1

• 1 other identifier: №10-18/11.2018
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Thin Endometrium

Keywords

platelet-rich plasma; infertility; endometrial cells

Outcome Measures

Primary Outcomes (5)

• Change in endometrial thickness after treatment compared with control.

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

  Baseline and 2 month

• The Doppler-assisted detection of the uterine spiral arteries

  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.

  1 month

• Study of the effect of therapy on the onset of pregnancy

  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.

  9 months

• The content of growth factor in autologous PRP

  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.

  3 month

• Phenotyping of cells isolated from endometrial biopsies

  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.

  3 month

Study Arms (4)

Conservative therapy

ACTIVE COMPARATOR

This is Group 1, whose patients received electrical impulse therapy using a BTL-4000 Premium G device (BTL Medical Technologies, Czech Republic) starting from day 5-7 of menstrual cycle for 10-12 days daily.

Procedure: Conservative therapy

PRP injection

EXPERIMENTAL

This is Group 2, whose patients received single intraendometrial injections of autologous PRP during proliferative phase (day 6-9) of menstrual cycle.

Biological: PRP injection

Injection of PRP after conservative therapy

EXPERIMENTAL

This is Group 3, whose patients received electrical impulse therapy identically with Group 1 during the first menstrual cycle. In the second cycle, the patients received autologous PRP injections identically with Group 2.

Biological: Injection of PRP after conservative therapy

Injection of PRP with endometrial cells

EXPERIMENTAL

This is Group 4, whose patients received single intraendometrial injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP during proliferative phase (day 6-9) of menstrual cycle.

Biological: Injection of PRP with endometrial cells

Interventions

Conservative therapy PROCEDURE

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

Conservative therapy

PRP injection BIOLOGICAL

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

PRP injection

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 after conservative therapy

Injection of PRP with endometrial cells BIOLOGICAL

This intervention consisted of injecting endometrial cells suspended in prp

Injection of PRP with endometrial cells

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare: lead
• Sechenov University: collaborator

Study Sites (1)

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

Moscow, 117997, Russia

Location

MeSH Terms

Conditions

Infertility

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Inna Apolikhina, MD

  FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian Federation

  STUDY DIRECTOR

• Zulfiia Efendieva, PhD

  FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian Federation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 13, 2022
• Study Start: October 1, 2018
• Primary Completion: January 11, 2021
• Study Completion: March 1, 2021
• Last Updated: July 13, 2022

Record last verified: 2022-06

Locations

RU (1)