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.: PACTR201604001405465 Date of Approval: 29/12/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Role of Endometrial Scratch in UnExplained infertility (RESCUE); A randomized clinical trial
Official scientific title Randomized controlled trial of Endometrial Injury in Unexplained infertility
Brief summary describing the background and objectives of the trial Endometrial curettage (injury) has been shown to improve the pregnancy and live birth rate following recurrent implantation failure with 3 systematic reviews showing consistently improved pregnancy and live birth rate when endometrial injury (EI)or scratch is done in the luteal phase preceding IVF treatment. The exact mechanism of action of EI is however is not clearly understood. Proposed mechanism of actions include promoting recruitment of a more favourable repertoire of immunological cells in the endometrium with a profile of growth factors and inflammatory cytokines conducive of implantation. Although the role of endometrial injury has been investigated in ART population its role as a primary tool for infertility treatment outside IVF treatment is not clearly established. In patients with unexplained infertility it is possible that one of the underlying mechanisms is a defective implantation process which could be corrected by endometrial injury. One RCT has shown an impressive improvement in cumulative pregnancy rate of 25.9% within 6 month of endometrial injury as compared with 9.8% within 6 months without EI in patients with unexplained infertility. This findings has not been corroborated by other RCTS. In this study we aim to investigate the role of endometrial injury in treatment of unexplained infertility and to have more insight on the potential underlying mechanisms of its action.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RESCUE
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 01/03/2016
Actual trial start date 01/03/2016
Anticipated date of last follow up 04/09/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 136
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised computer generated random numbers sealed opaque enveloppes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Endometrial injury( scratch) at time of laparoscopy twice 1 minute Gentle endometrial curretage with a sharp curette at time of diagnostic laparoscopy for infertility with endometrial biopsy and will be repeated once at 3 months follow-up with pipelle in outpatient clinic 68
Control Group sham scratch Twice 1 minute sham endometrial scratch with use of pipelle of endocervical canal 68 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Female age is < 35 years - Duration of subfertility <3 years - Unexplained infertility (confirmed with semen analysis, basic hormonal profile, pelvic ultrasound and diagnostic laparoscopy and dye test) - No history of previous ART - infertility due to male,tubal,anovulatory factors - presence of endometrial pathology as polyp or submucous fibroids - Abnormal genital tract bleeding - if any of the inclusion criteria is not fulfilled 18 Year(s) 35 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 07/09/2015 Minia faculty of Medicine Board
Ethics Committee Address
Street address City Postal code Country
Minia university Campus El-Minia 61111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cumulative pregnancy rate at 6 months follow-up
Secondary Outcome Time to pregnancy within 6 months of follow up time to achieve pregnancy individually is measured in days
Secondary Outcome clinical pregnancy rate Number of individual pregnancies achieved over the number of whole participants in the group assessed monthly
Secondary Outcome Miscarriage rate the number of early ( biochemical) and clinical miscarriages occuring in each group assessed monthly
Secondary Outcome Complications bleeding,infection,severe reaction (e.g) vasovagal occuring in particpants within the first 4 weeks after the intervention and any patient reported complaints
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia University Maternity Hospital Minia University campus El-Minia 61111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minia university Minia University campus El-Minia 61111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minia university postgraduate research office Minia University campus El-Minia 61111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Reham elkateeb Minia University campus El-Minia 61111 Egypt
Mohammed Khairy Minia university maternity hospital-Minia University campus El-Minia 61111 Egypt
Ahmed Ezz Eldin Mahran Minia university maternity hospital-Minia University campus El-Minia 61111 Egypt
Mahmoud Hosny Minia university maternity hospital-Minia University campus El-Minia 61111 Egypt
Ameer ElSherif Minia university maternity hospital-Minia University campus El-Minia 61111 Egypt
Hiathm Bahaa shalabi street Minia 61111 Egypt
Nisreen Dahi shalabi street Minia 61111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Khairy mkhairymaklad1973@yahoo.co.uk +2086236446 35 Ramses street
City Postal code Country Position/Affiliation
El-Minia 61111 Egypt lecturer of obstetrics and Gynaecology
Role Name Email Phone Street address
Public Enquiries Mohammed Khairy mkhairymaklad1973@yahoo.co.uk 0020862366446 Minia university Campus-Minia university maternity hospital
City Postal code Country Position/Affiliation
El-Minia 61111 Egypt Lecturer of obstetrics and Gynaecology
Role Name Email Phone Street address
Scientific Enquiries Mohammed Khairy mkhairymaklad1973@yahoo.co.uk 0020862366446
City Postal code Country Position/Affiliation
El-Minia 61111 Egypt Lecturer of obstetrics and Gynaecology
REPORTING
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