Recurrent Implantation FailureNCT02752568
Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure
A study testing endometrial scratch and assisted hatching in people with Recurrent Implantation Failure, run by Kasr El Aini Hospital.
Trial summary
300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Recurrent Implantation Failure
- What is being tested?
- endometrial scratch and assisted hatching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- recurrent implantation failure
- normal uterine cavity by transvaginal ultrasound
Who cannot join
- endometrial polyp or fibroid distorting the endometrium
- hydrosalpinx
- preimplantation genetic diagnosis
- severe male factor
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure.A Comparative Study
300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group
Read the detailed description
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
- Recurrent Implantation Failure
- Being tested
- endometrial scratch, assisted hatching, controlled ovarian hyperstimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial scratchProcedure or surgery
Also called endometrial injury
midluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation
assisted hatchingProcedure or surgery
Also called laser hatching
using Octax laser 20120644-laser 5452
controlled ovarian hyperstimulationProcedure or surgery
using merional\&/ or fostimon doses individualized as judged by patient age \& ovarian reserve \& monitored by follicular size \& serum estradiol
| Study group | Role | What they receive |
|---|---|---|
| Endometrial scratch group | Active comparator | endometrial scratch controlled ovarian hyperstimulation Receives: Procedure: endometrial scratch; Procedure: controlled ovarian hyperstimulation |
| Assisted hatching group | Active comparator | assisted hatching controlled ovarian hyperstimulation Receives: Procedure: assisted hatching; Procedure: controlled ovarian hyperstimulation |
| ovarian stimulation only group | Sham comparator | controlled ovarian hyperstimulation Receives: Procedure: controlled ovarian hyperstimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with positive pregnancy test
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Implantation FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, suzy abdelaziz Abdelhamid, Kasr El Aini Hospital
- Investigators
- suzy abdelaziz, lecturer, Principal investigator, kasrelaini hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752568
- Sponsor's protocol ID
- ivfobgyn
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2016
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33730422
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisted Hatching Versus Endometrial Scratch in Recurrent Implantation Failure.A Comparative Study
- ClinicalTrials.gov ID
- NCT02752568
- Acronym / sponsor ID
- ivfobgyn
- Conditions
- Recurrent Implantation Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
300 recurrent implantation failure patients will be alternatively assigned to assisted hatching , endometrial scratch , and no treatment ,100 patients in each group
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Endometrial scratch group | Active comparator | Procedure: endometrial scratch, Procedure: controlled ovarian hyperstimulationendometrial scratch controlled ovarian hyperstimulation |
| Assisted hatching group | Active comparator | Procedure: assisted hatching, Procedure: controlled ovarian hyperstimulationassisted hatching controlled ovarian hyperstimulation |
| ovarian stimulation only group | Sham comparator | Procedure: controlled ovarian hyperstimulationcontrolled ovarian hyperstimulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- recurrent implantation failure
- normal uterine cavity by transvaginal ultrasound
Key exclusion criteria (4 listed)
- endometrial polyp or fibroid distorting the endometrium
- hydrosalpinx
- preimplantation genetic diagnosis
- severe male factor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endometrial scratchAlso: endometrial injurymidluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation | Procedure or surgery | Endometrial scratch group |
| assisted hatchingAlso: laser hatchingusing Octax laser 20120644-laser 5452 | Procedure or surgery | Assisted hatching group |
| controlled ovarian hyperstimulationusing merional\&/ or fostimon doses individualized as judged by patient age \& ovarian reserve \& monitored by follicular size \& serum estradiol | Procedure or surgery | Assisted hatching group, Endometrial scratch group, ovarian stimulation only group |
Primary outcome
number of patients with positive pregnancy test
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2016.
- Derived from this study: PubMed 33730422Lacey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
suzy abdelaziz, lecturer principal investigator
kasrelaini hospital
Questions about this trial
What is this clinical trial studying?
A study testing endometrial scratch and assisted hatching in people with Recurrent Implantation Failure, run by Kasr El Aini Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact suzy abdelaziz, lecturer (01003726195, suzyabdelaziz92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with positive pregnancy test (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2016.