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

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

Status and phase: Completed; Phase 1

Conditions: Thin Endometrium

Treatments: Biological: PRP injection; Biological: Injection of PRP after conservative therapy; Procedure: Conservative therapy; Biological: Injection of PRP with endometrial cells

Study type: Interventional

Funder types: Other

Identifiers

NCT05455151

№10-18/11.2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 4 patient groups

Conservative therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Conservative therapy

PRP injection

Experimental group

Description:

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

Treatment:

Biological: PRP injection

Injection of PRP after conservative therapy

Experimental group

Description:

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.

Treatment:

Biological: Injection of PRP after conservative therapy

Injection of PRP with endometrial cells

Experimental group

Description:

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.

Treatment:

Biological: Injection of PRP with endometrial cells