Clinical trial NCT05455151: Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium
Official title: Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thin Endometrium
Keywords: platelet-rich plasma
infertility
endometrial cells
Lead sponsor: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Sponsor class: OTHER_GOV
Collaborators: name: Sechenov University
First posted: 2022-07-13
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in endometrial thickness after treatment compared with control.
timeFrame: Baseline and 2 month
measure: The Doppler-assisted detection of the uterine spiral arteries
timeFrame: 1 month
measure: Study of the effect of therapy on the onset of pregnancy
timeFrame: 9 months
measure: The content of growth factor in autologous PRP
timeFrame: 3 month
measure: Phenotyping of cells isolated from endometrial biopsies
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Study officials:
affiliation: FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian Federation
name: Inna Apolikhina, MD
role: STUDY_DIRECTOR
affiliation: FSBI "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I.Kulakov" Ministry of Healthcare of the Russian Federation
name: Zulfiia Efendieva, PhD
role: PRINCIPAL_INVESTIGATOR
References: