Autologous Intrauterine Platelet-Rich Plasma Instillation And Endometrial Scratching for Thinned Endometrium

January 22, 2020 updated by: Mohamed Mohsen Ahmed Mostafa Abo elnasr, Suez Canal University

Randomized Clinical Trial Between Autologous Intrauterine Platelet-Rich Plasma Instillation And Three Snip Hysteroscopic Endometrial Scratching for Thinned Endometrium

aim of that study is to compare the effect between autologous intrauterine Platelet-Rich Plasma instillation and three snip hysteroscopic endometrial scratching for thinned endometrium.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Embryo implantation is a very delicate and well-orchestrated process that is governed by the interaction between several maternal and embryonic factors, ultimately resulting in adherence of the blastocyst to the endometrium. For a short period of time during the normal menstrual cycle, the endometrium represents the fertile "soil" for the implanting embryo. The human endometrium undergoes complex changes, in response to circulating estrogen and progesterone, which culminate at the mid-luteal phase of the menstrual cycle when it becomes suitable to host the blastocyst.

In clinical practice, a thin endometrium, unresponsive to conventional therapies, usually results in cycle cancellation and embryo cryopreservation. The evaluation of an adequate endometrial growth is performed using grey-scale ultrasound. The minimal endometrial thickness required for embryo transfer is now considered about 7 mm at the end of natural or medically induced follicular phase Local injury to the endometrium has been proposed as a means to improve implantation in women with RIF. Initial non-randomized studies showed a doubling of implantation rates after 2-4 endometrial injuries performed at different time points of the menstrual cycle in women with previous implantation failure . Following that, a number of randomized trials focusing on women with RIF have been conducted. The majority of the trials have demonstrated significant improvements in implantation rates, clinical pregnancy rates and/or live birth rates following endometrial injury performed in the preceding cycle Platelet rich plasma (PRP) represents a relatively new approach in regenerative medicine. It is obtained from patient's own blood and contains different growth factors and other biomolecules necessary for wound healing. Platelet rich plasma (PRP) therapy has accumulated considerable attention over the two last decades, mainly due to its potential ability in regenerative medicine. Platelets as a main components of the PRP, contain more than 1100 different proteins, with numerous post-translational modifications, resulting in over 1500 protein-based bioactive factors These factors include immune system messengers, growth factors, enzymes and their inhibitors and factors which can participate in tissue repair and wound healing. Another important characteristic of PRP is that represents an autologous product, which is prepared from the patient's own blood. Therefore, the use of autologous PRP eliminates any concerns about the risk of crossed contamination, disease transmission or immune reactions

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Endometrial thickness < 7 mm under estrogen replacement therapy or repeated implantation failure Age between 18 and 38years

Exclusion Criteria:

Age < 18 and > 46 years Pregnancy Bleeding diathesis Previous uterine surgery (miomectomy, cesarean section, etc...) Platelet count < 105/μL Hemoglobin < 10 g/dL Presence of a tumor in the wound bed or metastatic disease Current diagnosis of cancer Other concomitant active infections Other factors of infertility ( PCO, tubal block, congenital anomalies, genetic malformation, male infertility)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: platelet rich plasma preparation

  • About 15 ml of autologous blood from the patient was collected slowly in 20 ml syringe containing 1.5 ml anticoagulant citrate dextrose solution A (ACDA) under complete aseptic precautions.

    2- Blood was mixed by swinging the syringe slowly. 3- By using 18G needle, the gathered blood was transfused into tube maintaining a slope of 45°.

    4- The centrifugation step was then done by using non digital angle type centrifuge :the tube was put with water tube on the opposite side to achieve centrifuge balance.

    5- The centrifugation occurred in one step by power 3600 RPM for 6 minutes. 6- The buffy coat was elevated up to the buffy coat line (Figure 1). 7- the buffy coat (2-3 ml PRP) was extracted from slim neck by tornado technique so that sunk platelets can be floated and drawn easily.

    8- the remaining platelet poor plasma(PPP) was drawn using 5 cc syringe. then inserted by ovum pick up needle into subendometrium
Biological: platlet rich plasma

Drug: PRP PRP subendometrial infusion

Device: ovum oickup needle PRP subendometrial infusion by hysteroscopic guided ovum pickup needle day 9 of the cycle
Active Comparator: endometrial scratch
using scissor of hysteroscopr 3 snips was done in the fundus
Procedure: endometrial scratch
Three Snip Hysteroscopic Endometrial Scratching in luteal phase of preceeding cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial thickness
Time Frame: 24-48h after intervention
Endometrial thickness > 7 mm measured by means of transvaginal ultrasound
24-48h after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive pregnancy test rate
Time Frame: Approximately 4 weeks after treatment
Positive pregnancy test rate
Approximately 4 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Study Chair: Mohamed M Farrag, Ph.D, Professor
  • Study Director: Elham H Madney, Ph.D, assisted professor
  • Principal Investigator: Rasha E Khamiss, PH.D, lecturar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 23, 2020

Primary Completion (Anticipated)

March 10, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • prp thinned endometrium

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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