InfertilityNCT03748238
Endometrial Injury In Recurrent Implantation Failure
A study testing Endometrial Injury with Hysteroscopy in people with Infertility and Endometrial Diseases, run by Gurgan Clinic at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate that the efficacy of the endometrial injury before IVF in recurrent implantation failure patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Endometrial Diseases
- What is being tested?
- Endometrial Injury with Hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to Jan 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women under the age of 40 who met the RIF definition
- Patients whose follicle-stimulating hormone (FSH) levels were ≤ 15 IU/mL
Who cannot join
- Patients with congenital uterine anomalies
- Patients with Asherman's syndrome
- Patients with uterine cavity distorted by myoma or endometrial polyps
- Patients with confirmed endometriosis or endometrioma
- Patients with BMI of <18.5 and >29.9
Trial locations and contacts
1 site in 1 country.
Muberra Namlı Kalem, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gurgan Clinic IVF and Women Health Center
Ankara, Cankaya, 06640
Ziya Kalem, MD, 0905326922383, ziyakalem@hotmail.com
About this study
Official title: Systematic And Standardized Hysteroscopic Endometrial Injury For Treatment Of Recurrent Implantation Failure
The aim of this study is to investigate that the efficacy of the endometrial injury before IVF in recurrent implantation failure patients.
Read the detailed description
This is a prospective and randomized controlled trial investigating the effect of hysteroscopic endometrial injury for treatment of recurrent implantation failure. Approximately 230 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years will be randomized into two groups. Injury group will receive endometrial injury during their hysteroscopic procedure, whereas the control group (n=115) did not. This study will investigate that, whether the endometrial injury is beneficial in recurrent implantation failure patients to increase the odds of clinical pregnancy rates, live birth rates, and implantation rates.
- Conditions
- Infertility, Endometrial Diseases
- Being tested
- Endometrial Injury with Hysteroscopy
- Keywords
- Recurrent implantation failure, Endometrial injury, Implantation, Hysteroscopy
- Medical subject headings
- Infertility, Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endometrial Injury with HysteroscopyProcedure or surgery
All office hysteroscopy procedures will be done transvaginally under sedation with a 5 mm 30 degree lens supplied with a 5 F working channel continuous flow office hysteroscope (Bettocchi office hysteroscope, Karl Storz, Tuttlingen, Germany) without speculum or tenaculum. Briefly, following cervical passage and initial endometrial cavity investigation endometrial injury will be performed without energy modality (i.e. with scissors). Endometrial injury will perform first on the fundus by cutting into the endometrium (without injuring the myometrium) transversally. Later, vertical incisions will perform 0,5 cm apart each other, on the anterior and posterior walls of the uterus, 1-1.5 cm away from the fundus and one cut for each lateral wall
| Study group | Role | What they receive |
|---|---|---|
| Injury group | Experimental | Endometrial injury with hysteroscopy Receives: Procedure: Endometrial Injury with Hysteroscopy |
| Control group | No intervention | No hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Pregnancy
Blood concentration of beta-hcg
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start1 Nov 2018
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gurgan Clinic
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Muberra Namlı Kalem, Gurgan Clinic
- Investigators
- Ziya Kalem, MD, Principal investigator, Gurgan Clinic IVF and Women Health CenterHalil Ruso, Embryologist, Principal investigator, GurganClinic IVF and Women Health CenterAntonis Makrigiannakis, MD,Professor, Principal investigator, Greek University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748238
- Sponsor's protocol ID
- 201871
- Status last verified
- Jan 2019
- First submitted
- 14 Nov 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic And Standardized Hysteroscopic Endometrial Injury For Treatment Of Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT03748238
- Acronym / sponsor ID
- 201871
- Conditions
- Infertility, Endometrial Diseases
- Keywords
- Recurrent implantation failure, Endometrial injury, Implantation, Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Gurgan ClinicResearch network
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 20 Nov 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.
The aim of this study is to investigate that the efficacy of the endometrial injury before IVF in recurrent implantation failure patients.
Detailed description
This is a prospective and randomized controlled trial investigating the effect of hysteroscopic endometrial injury for treatment of recurrent implantation failure. Approximately 230 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years will be randomized into two groups. Injury group will receive endometrial injury during their hysteroscopic procedure, whereas the control group (n=115) did not. This study will investigate that, whether the endometrial injury is beneficial in recurrent implantation failure patients to increase the odds of clinical pregnancy rates, live birth rates, and implantation rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injury group | Experimental | Procedure: Endometrial Injury with HysteroscopyEndometrial injury with hysteroscopy |
| Control group | No intervention | –No hysteroscopy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women under the age of 40 who met the RIF definition
- Patients whose follicle-stimulating hormone (FSH) levels were ≤ 15 IU/mL
Key exclusion criteria (5 listed)
- Patients with congenital uterine anomalies
- Patients with Asherman's syndrome
- Patients with uterine cavity distorted by myoma or endometrial polyps
- Patients with confirmed endometriosis or endometrioma
- Patients with BMI of <18.5 and >29.9
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 Injury with HysteroscopyAll office hysteroscopy procedures will be done transvaginally under sedation with a 5 mm 30 degree lens supplied with a 5 F working channel continuous flow office hysteroscope (Bettocchi office hysteroscope, Karl Storz, Tuttlingen, Germany) without speculum or tenaculum. Briefly, following cervical passage and initial endometrial cavity investigation endometrial injury will be performed without energy modality (i.e. with scissors). Endometrial injury will perform first on the fundus by cutting into the endometrium (without injuring the myometrium) transversally. Later, vertical incisions will perform 0,5 cm apart each other, on the anterior and posterior walls of the uterus, 1-1.5 cm away from the fundus and one cut for each lateral wall | Procedure or surgery | Injury group |
Primary outcome
Positive Pregnancy
Time frame: 1month
Blood concentration of beta-hcg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- 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.
Muberra Namlı Kalem, MD contact
Ziya Kalem, MD principal investigator
Gurgan Clinic IVF and Women Health Center
Halil Ruso, Embryologist principal investigator
GurganClinic IVF and Women Health Center
Antonis Makrigiannakis, MD,Professor principal investigator
Greek University
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 Injury with Hysteroscopy in people with Infertility and Endometrial Diseases, run by Gurgan Clinic at 1 site in Turkey (Türkiye).
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 5 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 15 Jan 2019. 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 Turkey (Türkiye). 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?
Contact Timur Gurgan, MD,Professor (0905322317706, tgurgan@gurganclinic.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Pregnancy (time frame: 1month). 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 15 Jan 2019.