NCT03470298

Brief Summary

ES is a procedure used to help embryos to implant more successfully after In-Vitro Fertilization (IVF) , ICSI in patients who had failed cycles in spite of transfer of good quality embryos. New researches and evidence suggests that scratching the uterine endometrium causes a repair reaction in patients may increase embryo implantation rate . In spit of the optimum timing of scratching not finally determined, the usual timing to perform ES is approximately one week before starting IVF, ICSI treatment . our study aims to compare other time of scratching which is the scratching at retrieval time.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

March 7, 2018

Last Update Submit

March 16, 2018

Conditions

ICSI

Keywords

Endometrial ScratchingUnexplained infertilityICSI

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    delivery of a fetus after passing medico legal viability

    about 9 months

Secondary Outcomes (2)

  • implantation rate

    2 weeks after embryo transfer

  • Clinical pregnancy rate

    4 weeks after embryo transfer

Study Arms (2)

Mid luteal Endometrial Scratching (MLES)

ACTIVE COMPARATOR

Making injury to endometrium by using Manual Vacuum Aspiration cannula size 5 . At this arm scratching done at mid luteal phase (day21) of the cycle before induction for ICSI

Procedure: Endometrial scratching

Retrieval Endometrial Scratching (RES)

ACTIVE COMPARATOR

Making injury to endometrium by using Manual Vacuum Aspiration cannula size 5 .Here scratching done at same day of ovum pick up of ICSI cycle the difference only between arm of MLES and RES only in the timing of scratching .

Procedure: Endometrial scratching

Interventions

Endometrial scratchingPROCEDURE

The patients in study undergo endometrial scratch technique after being randomly assigned in to one of two groups . First group undergo oocyte pickup just after finishing oocyte pick up and the other group undergo oocyte pickup one week before starting COH.ManualVaccum Aspiration (MVA) size 5 moved from below upwards with suction ,scrachning anterior uterine wall then posterior then left lateral uterine wall then right lateral uterine wall and lastly fundus. All patients were prescribed vibramycine 100 mg twice daily for 3 days starting one day before procedure

Also known as: Endometrial injury
Mid luteal Endometrial Scratching (MLES)Retrieval Endometrial Scratching (RES)

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with at least one previous failed ICSI cycles, Good responders in the previous ICSI cycle and Less than or equal to 35 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility care unite,Mansoura university hospital.

Al Mansurah, Egypt

Location

Related Publications (1)

  • Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.

    PMID: 12798877BACKGROUND

Study Officials

  • Abdelhady A Zayed, Ass. prof.

    Mansoura university hospital ,Mansoura,Dakahlia,Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The patients in study undergo endometrial scratch technique after being randomly assigned in to one of two groups . First group undergo ES just after finishing oocyte pick up and the other group undergo ES one week before starting COH. Manual Vacuum Aspiration (MVA) size 5 moved from below upwards with suction ,scratching anterior uterine wall then posterior then left lateral uterine wall then right lateral uterine wall and lastly funds.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Obstetrics &Gynecology

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 19, 2018

Study Start

January 1, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

March 19, 2018

Record last verified: 2018-03

Locations

EG(1)