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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05455151
Other study ID # ?10-18/11.2018
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 1, 2018
Est. completion date March 1, 2021

Study information

Verified date June 2022
Source Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date March 1, 2021
Est. primary completion date January 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Conservative therapy
Conservative therapy to which the patients were subjected was the effect of an electrical impulse
Biological:
PRP injection
This intervention consisted of injecting platelet-rich plasma (PRP) into the endometrium
Injection of PRP after conservative therapy
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 intervention consisted of injecting endometrial cells suspended in prp

Locations

Country Name City State
Russian Federation Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare Moscow

Sponsors (2)

Lead Sponsor Collaborator
Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare Sechenov University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
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Not yet recruiting NCT04100655 - The Effect of the GM-CSF Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium N/A
Recruiting NCT04292886 - Thin Endometrium Undergoing Frozen-thawed Embryo Transfer N/A
Recruiting NCT06379659 - Effectiveness of Intrauterine Growth Hormone Administration as an add-on Therapy to Conventional Hormone Therapy Compared to Placebo in Patients With Thin Endometrium Undergoing Frozen Thawed Embryo Transfer Phase 1/Phase 2
Recruiting NCT06234540 - a-PRP Intrauterine Instillation in Women With Thin Endometrium N/A
Recruiting NCT03067623 - Autologous Platelet-Rich Plasma (PRP) and Endometrial Thickness Phase 2