Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202209756520785 Date of Registration: 22/09/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison Between Using Autologous Intrauterine Platelet-Rich Plasma Instillation And Three Snip Hysteroscopic Endometrial Scratching In Cases With Infertility Due To Thinned Endometrium
Official scientific title Comparison Between Using Autologous Intrauterine Platelet-Rich Plasma Instillation And Three Snip Hysteroscopic Endometrial Scratching In Cases With Infertility Due To Thinned Endometrium
Brief summary describing the background and objectives of the trial 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. In clinical practice, a thin endometrium, unresponsive to conventional therapies, usually results in cycle cancellation and embryo cryopreservation. 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 mean to improve implantation in women with repeated implantation failure(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 w omen with RIF have been conducted. The majority of the trials have demonstrated significant improvements in implantation rates. platelet rich plasma regulate cell migration, attachment, proliferation and differentiation, and promote extracellular matrix accumulation. So the aim of this study is to compare the pregnancy outcome of autologous intrauterine Platelet-Rich Plasma instillation and three snip hysteroscopic endometrial scratching in cases with infertility due to thinned endometrium attending to Suez Canal University hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/03/2019
Actual trial start date 01/03/2019
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date 30/06/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group endometrial scratch three snip hysteroscopic scratch mid luteal phase of the cycle preceding (7-10 days premenstrual) the cycle preceding endometrial scratch 20 Active-Treatment of Control Group
Experimental Group PRP group injection of PRP done using ovum pick up needle. same cycle PRP group 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female patient between 18-38 years with primary infertility in which: Persistent thin lining < 7mm on >1 cycle. Diagnosis of cancer. Cases of uterine myoma. Any structural or congenital malformation of the uterus. Cases of infertility due to tubal block. Other cases of female infertility as PCO, pituitary or Hypothalamic cause. Any significant comorbidity or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results. Infertility due to male factors. Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/02/2019 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pregnancy rates in both groups the same or next cycle
Secondary Outcome endometrial thickness in both groups the same or the next cycle
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital ring road kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed aboelnasr ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor seuz canal university ring road kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Mohsen Ahmed Abo ElNasr ring road kilo 4.5 ismailia Egypt
Mohamed Mouselhy Farrag ring road kilo 4.5 ismailia Egypt
Elham Hussein Madney ring road kilo 4.5 ismailia Egypt
Rasha ElSayed Khamiss ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed aboelnasr mohamedaboelnasr@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries rasha khamiss rashakhamees@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Scientific Enquiries mohamed aboelnasr mohamedaboelnasr@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data sharing is possible upon request and after approval of the research ethics committee Study Protocol after completion of data analysis after approval of the research ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information