Embryo ImplantationNCT03485235
Effect of Dilatation and Curettage on the Endometrial Receptivity
A study testing D&C and ICSI in people with Embryo Implantation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Effect of dilatation and curettage on the endometrial receptivity and pregnancy outcome in patients with recurrent implantation failure Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Embryo Implantation
- What is being tested?
- D&C and ICSI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Mar 2018to 10 Dec 2019
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All the patients had at least 3 failed trials of IVF-ET with day 5 fresh blastocyst transferred
- At least 10 high-grade embryos were obtained in the previous trials
- Level of AMH more than or equal 1.1 ng/ml.
- Age: Less than or equal to 35 years
Who cannot join
- Patients with uterine pathology e.g. myoma , Asherman syndrome, Septum ,adenomyosis
- Hydrosalpinx
- Endometriosis
- patients with diagnosed autoimmune diseases affecting pregnancy e.g. S.L.E.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dilatation and Curettage on the Endometrial Receptivity and Pregnancy Outcome in Patients With Recurrent Implantation Failure
Effect of dilatation and curettage on the endometrial receptivity and pregnancy outcome in patients with recurrent implantation failure
- Conditions
- Embryo Implantation
- Being tested
- D&C, ICSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D&CProcedure or surgery
Dilatation and curettage
ICSIProcedure or surgery
Intra Cytoplasmic Sperm Injection
| Study group | Role | What they receive |
|---|---|---|
| D&C | Experimental | Not described Receives: Procedure: D&C; Procedure: ICSI |
| No D&C | Other | Not described Receives: Procedure: ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start31 Mar 2018
- Primary completion1 Nov 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo ImplantationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed S Sweed, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485235
- Sponsor's protocol ID
- AS1764
- Status last verified
- Jan 2020
- First submitted
- 26 Mar 2018
- Last updated
- 28 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dilatation and Curettage on the Endometrial Receptivity and Pregnancy Outcome in Patients With Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT03485235
- Acronym / sponsor ID
- AS1764
- Conditions
- Embryo Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 31 Mar 2018 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 2 Apr 2018 (actual)
- 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.
Effect of dilatation and curettage on the endometrial receptivity and pregnancy outcome in patients with recurrent implantation failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D&C | Experimental | Procedure: D&C, Procedure: ICSI |
| No D&C | Other | Procedure: ICSI |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All the patients had at least 3 failed trials of IVF-ET with day 5 fresh blastocyst transferred
- At least 10 high-grade embryos were obtained in the previous trials
- Level of AMH more than or equal 1.1 ng/ml.
- Age: Less than or equal to 35 years
Key exclusion criteria (4 listed)
- Patients with uterine pathology e.g. myoma , Asherman syndrome, Septum ,adenomyosis
- Hydrosalpinx
- Endometriosis
- patients with diagnosed autoimmune diseases affecting pregnancy e.g. S.L.E.
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 |
|---|---|---|
| D&CDilatation and curettage | Procedure or surgery | D&C |
| ICSIIntra Cytoplasmic Sperm Injection | Procedure or surgery | D&C, No D&C |
Primary outcome
Live Birth Rate
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D&C and ICSI in people with Embryo Implantation, run by Ain Shams University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth Rate (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2020.