NCT05987995

Brief Summary

Endometrial injury is one of the interventions suggested to improve the endometrial receptivity by enhancing the decidualization process, and so increasing the pregnancy rate

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 11, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

August 4, 2023

Last Update Submit

August 10, 2023

Conditions

Infertility

Keywords

Endometrial injuryICSIinfertilitypregnancy rate

Outcome Measures

Primary Outcomes (1)

  • pregnancy rate

    Quantitative beta HCG test is done

    15 days after HCG administration

Study Arms (2)

Endometrial injury group

EXPERIMENTAL

Endometrial injury was done on day 3-5 of stimulation, just after the cessation of menstruation. After the insertion of a vaginal speculum, the cervix was cleaned using a sterile saline solution. A pipelle endometrial sampler was introduced gently into the uterine cavity. The inner piston of the catheter was withdrawn to create suction, and injury (scratching) of the endometrium was done by moving the pipelle catheter up and down within the uterine cavity. The obtained tissues were seen in a transparent tube. If no tissues were seen in the tube, the procedure was repeated.

Procedure: Endometrial injury

Control group

NO INTERVENTION

no thing is done for this group

Interventions

Endometrial injuryPROCEDURE

A pipelle endometrial sampler was introduced gently into the uterine cavity. The inner piston of the catheter was withdrawn to create suction, and injury (scratching) of the endometrium was done by moving the pipelle catheter up and down within the uterine cavity

Endometrial injury group

Eligibility Criteria

AgeUp to 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsinfertile females that seeking pregnancy
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age \<40 year.
  • BMI 20-35 kg/m2.

You may not qualify if:

  • Age \>40 year
  • BMI \> 35
  • Uterine cavity abnormalities
  • poor quality embryos
  • Poor responders
  • Diagnosed sever endometriosis
  • Sever male factor
  • Declined to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tamer

Alexandria, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

September 11, 2022

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

August 14, 2023

Record last verified: 2022-09

Locations

EG(1)