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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-03-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Thin Endometrium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Conservative therapy

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.

Group Type ACTIVE_COMPARATOR

Conservative therapy

Intervention Type PROCEDURE

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

PRP injection

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

Group Type EXPERIMENTAL

PRP injection

Intervention Type BIOLOGICAL

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

Injection of PRP after conservative therapy

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.

Group Type EXPERIMENTAL

Injection of PRP after conservative therapy

Intervention Type 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

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.

Group Type EXPERIMENTAL

Injection of PRP with endometrial cells

Intervention Type BIOLOGICAL

This intervention consisted of injecting endometrial cells suspended in prp

Interventions

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Conservative therapy

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

Intervention Type PROCEDURE

PRP injection

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

Intervention Type BIOLOGICAL

Injection of PRP after conservative therapy

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

Intervention Type BIOLOGICAL

Injection of PRP with endometrial cells

This intervention consisted of injecting endometrial cells suspended in prp

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Inna Apolikhina, MD

Role: STUDY_DIRECTOR

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

Zulfiia Efendieva, PhD

Role: PRINCIPAL_INVESTIGATOR

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