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

NCT04240860 | Unknown Phase 2

• 1 other identifier: prp thinned endometrium
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infertility Due to Nonimplantation

Outcome Measures

Primary Outcomes (1)

• Endometrial thickness

  Endometrial thickness \> 7 mm measured by means of transvaginal ultrasound

  24-48h after intervention

Secondary Outcomes (1)

• Positive pregnancy test rate

  Approximately 4 weeks after treatment

Study Arms (2)

platelet rich plasma preparation

EXPERIMENTAL

* 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

endometrial scratch

ACTIVE COMPARATOR

using scissor of hysteroscopr 3 snips was done in the fundus

Procedure: endometrial scratch

Interventions

platlet rich plasma BIOLOGICAL

Drug: PRP PRP subendometrial infusion Device: ovum oickup needle PRP subendometrial infusion by hysteroscopic guided ovum pickup needle day 9 of the cycle

platelet rich plasma preparation

endometrial scratch PROCEDURE

Three Snip Hysteroscopic Endometrial Scratching in luteal phase of preceeding cycle

endometrial scratch

Eligibility Criteria

• Age: 18 Years - 38 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Suez Canal University: lead

Related Publications (5)

• Zadehmodarres S, Salehpour S, Saharkhiz N, Nazari L. Treatment of thin endometrium with autologous platelet-rich plasma: a pilot study. JBRA Assist Reprod. 2017 Feb 1;21(1):54-56. doi: 10.5935/1518-0557.20170013.

  PMID: 28333034 BACKGROUND

• Molina A, Sanchez J, Sanchez W, Vielma V. Platelet-rich plasma as an adjuvant in the endometrial preparation of patients with refractory endometrium. JBRA Assist Reprod. 2018 Mar 1;22(1):42-48. doi: 10.5935/1518-0557.20180009.

  PMID: 29303234 BACKGROUND

• Tandulwadkar SR, Naralkar MV, Surana AD, Selvakarthick M, Kharat AH. Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. J Hum Reprod Sci. 2017 Jul-Sep;10(3):208-212. doi: 10.4103/jhrs.JHRS_28_17.

  PMID: 29142450 BACKGROUND

• Nastri CO, Ferriani RA, Raine-Fenning N, Martins WP. Endometrial scratching performed in the non-transfer cycle and outcome of assisted reproduction: a randomized controlled trial. Ultrasound Obstet Gynecol. 2013 Oct;42(4):375-82. doi: 10.1002/uog.12539. Epub 2013 Sep 2.

  PMID: 23754314 BACKGROUND

• Shokeir T, Ebrahim M, El-Mogy H. Hysteroscopic-guided local endometrial injury does not improve natural cycle pregnancy rate in women with unexplained infertility: Randomized controlled trial. J Obstet Gynaecol Res. 2016 Nov;42(11):1553-1557. doi: 10.1111/jog.13077. Epub 2016 Jul 1.

  PMID: 27363928 BACKGROUND

Study Officials

• Mohamed M Farrag, Ph.D

  professor

  STUDY CHAIR

• Elham H Madney, Ph.D

  assisted professor

  STUDY DIRECTOR

• Rasha E Khamiss, PH.D

  lecturar

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed M Aboelnasr, M.B.B.Ch.

CONTACT

201009988713; Aboelnasr91@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident in obs gyn department

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: January 27, 2020
• Study Start: January 23, 2020
• Primary Completion: March 10, 2020
• Study Completion: August 1, 2020
• Last Updated: January 27, 2020

Record last verified: 2020-01