Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure

NCT ID: NCT02752568

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Group 1 consists of 100 patients will undergo endometrial scratch followed by controlled ovarian hyperstimulation Group 2 consists of 100 patients will undergo controlled ovarian hyperstimulation\& assisted hatching Group 3 consists of 100 patients will undergo controlled ovarian hyperstimulation

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Recurrent Implantation Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endometrial scratch group

endometrial scratch controlled ovarian hyperstimulation

Group Type ACTIVE_COMPARATOR

endometrial scratch

Intervention Type PROCEDURE

midluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation

controlled ovarian hyperstimulation

Intervention Type PROCEDURE

using merional\&/ or fostimon doses individualized as judged by patient age \& ovarian reserve \& monitored by follicular size \& serum estradiol

Assisted hatching group

assisted hatching controlled ovarian hyperstimulation

Group Type ACTIVE_COMPARATOR

assisted hatching

Intervention Type PROCEDURE

using Octax laser 20120644-laser 5452

controlled ovarian hyperstimulation

Intervention Type PROCEDURE

using merional\&/ or fostimon doses individualized as judged by patient age \& ovarian reserve \& monitored by follicular size \& serum estradiol

ovarian stimulation only group

controlled ovarian hyperstimulation

Group Type SHAM_COMPARATOR

controlled ovarian hyperstimulation

Intervention Type PROCEDURE

using merional\&/ or fostimon doses individualized as judged by patient age \& ovarian reserve \& monitored by follicular size \& serum estradiol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

endometrial scratch

midluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation

Intervention Type PROCEDURE

assisted hatching

using Octax laser 20120644-laser 5452

Intervention Type PROCEDURE

controlled ovarian hyperstimulation

using merional\&/ or fostimon doses individualized as judged by patient age \& ovarian reserve \& monitored by follicular size \& serum estradiol

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

endometrial injury laser hatching

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* recurrent implantation failure
* normal uterine cavity by transvaginal ultrasound

Exclusion Criteria

* endometrial polyp or fibroid distorting the endometrium
* hydrosalpinx
* preimplantation genetic diagnosis
* severe male factor
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

suzy abdelaziz Abdelhamid

lecturer of obstetrics & gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

suzy abdelaziz, lecturer

Role: PRINCIPAL_INVESTIGATOR

kasrelaini hospital

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

suzy abdelaziz, lecturer

Role: CONTACT

01003726195

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33730422 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ivfobgyn

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.