Reproductive IssuesNCT05590104
Hysteroscopic Isthmocele Repair on IVF Outcome
A study testing Hysteroscopic CS scar defect repair in people with Reproductive Issues and Cesarean Section; Dehiscence, run by HealthPlus Fertility Center at 2 sites in United Arab Emirates.
Trial summary
Hysteroscopic Isthmocele repair on IVF outcome It aims to assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer. Patients who were diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer… Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Reproductive Issues, Cesarean Section; Dehiscence, Intrauterine Disorder
- What is being tested?
- Hysteroscopic CS scar defect repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 26 Mar 2023to 30 May 2024
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed CS scar defect by TVUS
- At least one failed trial of euploid embryo transfer
- Planning for a trial of single euploid embryo transfer
Who cannot join
- Residual myometrial thickness less than 3 mm
- Any congenital uterine abnormalities.,
- Prescence of intrauterine lesions e.g. polyp, fibroid, Endometriosis or adenomyosis, Hydrosalpinx, Chronic endometritis, Previous CS scar defect repair.
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites, 2 recruiting
- Recruiting
Healthplus fertility center
Abu Dhabi, UAE, 11231
Ahmed Elbohoty, 00971504067530, elbohoty79@gmail.com
600503535
- Recruiting
Healthplus fertility center
Abu Dhabi
Ahmed Elbohoty, PHD, 00971504067530, elbohoty79@gmail.com
About this study
Official title: Effect of Hysteroscopic Isthmocele Repair on IVF Outcome: A Randomized Controlled Trial
Hysteroscopic Isthmocele repair on IVF outcome It aims to assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer.
Patients who were diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer will be assed for study eligibility. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome.
Read the detailed description
Hysteroscopic Isthmocele repair on IVF outcome Background: Uterine niche is a very common finding in women with previous caesarean section. Subfertility can be associated finding and IVF outcome can be affected by its presence. It is not yet if its treatment before IVF trial could improve the outcome of IVF cycle.
Objectives: assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer.
Methods This prospective randomized controled will be conducted at Healthplus fertility center. The population of the study will be Patients who was diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome. Seconday outcomes are Complications following hysteroscopic CS scar repair, the need of aspiration of intrauterine fluid before embryo transfer, early pregnancy complications, Caesarean section scar dehiscence or rupture and live birth rate.
- Being tested
- Hysteroscopic CS scar defect repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic CS scar defect repairProcedure or surgery
Dilatation of the cervix till 7 mm. Introduce the resctoscope through the cervix. The surgical correction of the isthmocele is done by resection of the inferior and superior edges or just the inferior edge of the defect with a resectoscopic loop, using pure cutting current, until reaching the muscular layer. Coagulation of fragile vessels at the base or even entire niche. At the end of procedure, flow and pressure of distending medium can be reduced to ensure adequate haemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Hysteroscopic CS scar defect repair | Experimental | Patient who is randomized to the hysteroscopic repair of CS scar defect will be prepared to have the surgery postmenstrual.
The surgery will be under general anasthesia. The participants will be placed in the lithotomy position. The cervix will be visualized using a Sims speculum and grasped using a single-toothed tenaculum, and the cervix, fornix, and vagina will be cleaned.
Dilatation of the cervix till 7 mm. Introduce the resctoscope through the cervix. The surgical correction of the isthmocele is done by resection of the inferior and superior edges or just the inferior edge of the defect with a resectoscopic loop, using pure cutting current, until reaching the muscular layer. Coagulation of fragile vessels at the base or even entire niche. At the end of procedure, flow and pressure of distending medium can be reduced to ensure adequate haemostasis. After that the patient will be prepared for another euoploid embryo transfer. Receives: Procedure: Hysteroscopic CS scar defect repair |
| Expectant management | No intervention | Patient who is randomized to the expectant management will be prepared for another embryo transfer for euoploid embryo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Clinical pregnancy
detection of intrauterine pregnancy with a detectable fetal heart pulsation by transvaginal ultrasound scan
Measured: at 7 weeks of gestation or beyond
Secondary outcomes (5)
Rate of Complications following hysteroscopic CS scar repair
uterine perforation, fluid overload and endometritis
Measured: up to 6 weeks
Rate of Need of aspiration of intrauterine fluid
Presence intrauterine fluid collection at the time of embryo transfer which should be aspirated before embryo transfer
Measured: During the preparation of embryo transfer. Through study completion, an average of 1 year
Rate of Early pregnancy complications
Ectopic pregnancy or Miscarriage
Measured: 12 weeks gestation
Rate of Caesarean section scar dehiscence or rupture
Rupture of CS scar during the antenatal period or presence of CS scar wound dehiscence at the time of delivery
Measured: Within 40 weeks of pregnancy
Rate of delivery of a living baby
Delivery of a living baby after 24 weeks gestation
Measured: Within 40 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start26 Mar 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive IssuesStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPlus Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Hassan Hamed Elbohoty, HealthPlus Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590104
- Sponsor's protocol ID
- HIROIO
- Status last verified
- Mar 2023
- First submitted
- 12 Oct 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This prospective randomized controlled will be conducted at Healthplus fertility center. The population of the study will be Patients who was diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome. Secondary outcomes are Complications following hysteroscopic CS scar repair, the need of aspiration of intrauterine fluid before embryo transfer, early pregnancy complications, Caesarean section scar dehiscence or rupture and live birth rate.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hysteroscopic Isthmocele Repair on IVF Outcome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05590104
- Acronym / sponsor ID
- HIROIO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- HealthPlus Fertility CenterUniversity, hospital or other
- Study start
- 26 Mar 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 21 Oct 2022 (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.
Hysteroscopic Isthmocele repair on IVF outcome It aims to assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer.
Patients who were diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer will be assed for study eligibility. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome.
Detailed description
Hysteroscopic Isthmocele repair on IVF outcome Background: Uterine niche is a very common finding in women with previous caesarean section. Subfertility can be associated finding and IVF outcome can be affected by its presence. It is not yet if its treatment before IVF trial could improve the outcome of IVF cycle.
Objectives: assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer.
Methods This prospective randomized controled will be conducted at Healthplus fertility center. The population of the study will be Patients who was diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome. Seconday outcomes are Complications following hysteroscopic CS scar repair, the need of aspiration of intrauterine fluid before embryo transfer, early pregnancy complications, Caesarean section scar dehiscence or rupture and live birth rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysteroscopic CS scar defect repair | Experimental | Procedure: Hysteroscopic CS scar defect repairPatient who is randomized to the hysteroscopic repair of CS scar defect will be prepared to have the surgery postmenstrual. The surgery will be under general anasthesia. The participants will be placed in the lithotomy position. The cervix will be visualized using a Sims speculum and grasped using a single-toothed tenaculum, and the cervix, fornix, and vagina will be cleaned. Dilatation of the cervix till 7 mm. Introduce the resctoscope through the cervix. The surgical correction of the isthmocele is done by resection of the inferior and superior edges or just the inferior edge of the defect with a resectoscopic loop, using pure cutting current, until reaching the muscular layer. Coagulation of fragile vessels at the base or even entire niche. At the end of procedure, flow and pressure of distending medium can be reduced to ensure adequate haemostasis. After that the patient will be prepared for another euoploid embryo transfer. |
| Expectant management | No intervention | –Patient who is randomized to the expectant management will be prepared for another embryo transfer for euoploid embryo. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed CS scar defect by TVUS
- At least one failed trial of euploid embryo transfer
- Planning for a trial of single euploid embryo transfer
Key exclusion criteria (3 listed)
- Residual myometrial thickness less than 3 mm
- Any congenital uterine abnormalities.,
- Prescence of intrauterine lesions e.g. polyp, fibroid, Endometriosis or adenomyosis, Hydrosalpinx, Chronic endometritis, Previous CS scar defect repair.
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 |
|---|---|---|
| Hysteroscopic CS scar defect repairDilatation of the cervix till 7 mm. Introduce the resctoscope through the cervix. The surgical correction of the isthmocele is done by resection of the inferior and superior edges or just the inferior edge of the defect with a resectoscopic loop, using pure cutting current, until reaching the muscular layer. Coagulation of fragile vessels at the base or even entire niche. At the end of procedure, flow and pressure of distending medium can be reduced to ensure adequate haemostasis. | Procedure or surgery | Hysteroscopic CS scar defect repair |
Primary outcome
Rate of Clinical pregnancy
Time frame: at 7 weeks of gestation or beyond
detection of intrauterine pregnancy with a detectable fetal heart pulsation by transvaginal ultrasound scan
5 secondary outcomes
Rate of Complications following hysteroscopic CS scar repair
Time frame: up to 6 weeks
Rate of Need of aspiration of intrauterine fluid
Time frame: During the preparation of embryo transfer. Through study completion, an average of 1 year
Rate of Early pregnancy complications
Time frame: 12 weeks gestation
Rate of Caesarean section scar dehiscence or rupture
Time frame: Within 40 weeks of pregnancy
Rate of delivery of a living baby
Time frame: Within 40 weeks of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: Yes. This prospective randomized controlled will be conducted at Healthplus fertility center. The population of the study will be Patients who was diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome. Secondary outcomes are Complications following hysteroscopic CS scar repair, the need of aspiration of intrauterine fluid before embryo transfer, early pregnancy complications, Caesarean section scar dehiscence or rupture and live birth rate.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopic CS scar defect repair in people with Reproductive Issues and Cesarean Section; Dehiscence, run by HealthPlus Fertility Center at 2 sites in United Arab Emirates.
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 3 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 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Clinical pregnancy (time frame: at 7 weeks of gestation or beyond). 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 29 Mar 2023.