Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure
1 other identifier
interventional
300
0 countries
N/A
Brief Summary
300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 27, 2016
April 1, 2016
6 months
April 25, 2016
April 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
number of patients with positive pregnancy test
2 months
Study Arms (3)
Endometrial scratch group
ACTIVE COMPARATORendometrial scratch controlled ovarian hyperstimulation
Assisted hatching group
ACTIVE COMPARATORassisted hatching controlled ovarian hyperstimulation
ovarian stimulation only group
SHAM COMPARATORcontrolled ovarian hyperstimulation
Interventions
midluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation
using Octax laser 20120644-laser 5452
using merional\&/ or fostimon doses individualized as judged by patient age \& ovarian reserve \& monitored by follicular size \& serum estradiol
Eligibility Criteria
You may qualify if:
- recurrent implantation failure
- normal uterine cavity by transvaginal ultrasound
You may not qualify if:
- endometrial polyp or fibroid distorting the endometrium
- hydrosalpinx
- preimplantation genetic diagnosis
- severe male factor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lacey L, Hassan S, Franik S, Seif MW, Akhtar MA. Assisted hatching on assisted conception (in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI)). Cochrane Database Syst Rev. 2021 Mar 17;3(3):CD001894. doi: 10.1002/14651858.CD001894.pub6.
PMID: 33730422DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
suzy abdelaziz, lecturer
kasrelaini hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of obstetrics & gynecology
Study Record Dates
First Submitted
April 25, 2016
First Posted
April 27, 2016
Study Start
May 1, 2016
Primary Completion
November 1, 2016
Study Completion
December 1, 2016
Last Updated
April 27, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share