Invitro FertilizationNCT02660125
Endometrial Injury and Implantation Rates Before First ICSI Cycle
A study testing Endometrial scratch injury in people with Invitro Fertilization, run by Cairo University at 1 site in Egypt.
Trial summary
Midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix, the step that will be beneficial to embryo transfer procedure. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Invitro Fertilization
- What is being tested?
- Endometrial scratch injury
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Mar 2017
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- subfertile women indicated for ICSI.
- normal uterine cavity demonstrated by transvaginal ultrasound and hystrogram.
- FSH<10mIU/mL on day 3 of her cycle.
Who cannot join
- presence of endometrial polyp or fibroid distorting the uterine cavity.
- hydrosalpinx.
- ICSI carried out for preimplantation genetic diagnosis.
- FSH>10mIU\mL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Local Endometrial Injury Improve Implantation Rates in Women Undergoing Their First ICSI Cycle.
Midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix, the step that will be beneficial to embryo transfer procedure.
Controller ovarian hyperstimulation; will be done using the long luteal phase agonist protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3 FSH and antral follicular count and previous history of ovarian response).
Read more
Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when there is >=1 follicle >=18 mm. and >=3 follicles >=16 mm. Ultasound guided oocyte retrieval will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3 after oocyt retrieval according to number and quality of embryos.
Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.
- Conditions
- Invitro Fertilization
- Being tested
- Endometrial scratch injury
- Keywords
- ICSI, endometrial injury, implantation rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial scratch injuryProcedure or surgery
midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix
| Study group | Role | What they receive |
|---|---|---|
| endometrial scratch injury | Active comparator | endometrial scratch done before ICSI cycle Receives: Procedure: Endometrial scratch injury |
| control | No intervention | IcSI cycle without prior endometrial injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rate
number of sacs identifiable through ultrasonography divided by the number of embryos transferred
Measured: 14 days after embryo transfer
clinical pregnancy rate
the detection of fetal cardiac activity within a gestational sac on ultrasonography examination
Measured: 4 weeks after embryo transfer
Secondary outcomes (2)
multiple pregnancy rate
number of patients who had a multifetal pregnancy divided by the total number of clinical pregnancies
Measured: 4 weeks after embryo transfer
abortion rate
number of patients who had a spontaneous abortion before 12 weeks of pregnancy divided by total number of clinical pregnancies
Measured: 12 weeks of gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017
- Study completionMar 2017
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 Invitro FertilizationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660125
- Sponsor's protocol ID
- 144
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2016
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Maged AM, Rashwan H, AbdelAziz S, Ramadan W, Mostafa WAI, Metwally AA, Katta M. Randomized controlled trial of the effect of endometrial injury on implantation and clinical pregnancy rates during the first ICSI cycle. Int J Gynaecol Obstet. 2018 Feb;140(2):211-216. doi: 10.1002/ijgo.12355. Epub 2017 Nov 18.
PubMed 29048754
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Local Endometrial Injury Improve Implantation Rates in Women Undergoing Their First ICSI Cycle.
- ClinicalTrials.gov ID
- NCT02660125
- Acronym / sponsor ID
- 144
- Conditions
- Invitro Fertilization
- Keywords
- ICSI, endometrial injury, implantation rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 21 Jan 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.
Midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix, the step that will be beneficial to embryo transfer procedure.
Controller ovarian hyperstimulation; will be done using the long luteal phase agonist protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3 FSH and antral follicular count and previous history of ovarian response).
Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when there is >=1 follicle >=18 mm. and >=3 follicles >=16 mm. Ultasound guided oocyte retrieval will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3 after oocyt retrieval according to number and quality of embryos.
Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endometrial scratch injury | Active comparator | Procedure: Endometrial scratch injuryendometrial scratch done before ICSI cycle |
| control | No intervention | –IcSI cycle without prior endometrial injury |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- subfertile women indicated for ICSI.
- normal uterine cavity demonstrated by transvaginal ultrasound and hystrogram.
- FSH<10mIU/mL on day 3 of her cycle.
Key exclusion criteria (4 listed)
- presence of endometrial polyp or fibroid distorting the uterine cavity.
- hydrosalpinx.
- ICSI carried out for preimplantation genetic diagnosis.
- FSH>10mIU\mL.
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 scratch injurymidluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix | Procedure or surgery | endometrial scratch injury |
Primary outcome
implantation rate
Time frame: 14 days after embryo transfer
number of sacs identifiable through ultrasonography divided by the number of embryos transferred
clinical pregnancy rate
Time frame: 4 weeks after embryo transfer
the detection of fetal cardiac activity within a gestational sac on ultrasonography examination
2 secondary outcomes
multiple pregnancy rate
Time frame: 4 weeks after embryo transfer
abortion rate
Time frame: 12 weeks of gestational age
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 1 Feb 2024.
- Derived from this study: PubMed 29048754Maged AM, Rashwan H, AbdelAziz S, Ramadan W, Mostafa WAI, Metwally AA, Katta M. Randomized controlled trial of the effect of endometrial injury on implantation and clinical pregnancy rates during the first ICSI cycle. Int J Gynaecol Obstet. 2018 Feb;140(2):211-216. doi: 10.1002/ijgo.12355. Epub 2017 Nov 18.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Maged principal investigator
Kasr Alainy medical school
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endometrial scratch injury in people with Invitro Fertilization, run by Cairo 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 3 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 1 Feb 2024. 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?
implantation rate (time frame: 14 days after embryo transfer). The study lists 2 primary outcomes in all. 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 NCT02660125, 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 1 Feb 2024.