Recurrent Implantation FailureNCT06847386
Effect of Hysteroscopic Metroplasty on Reproductive Outcome in Patients with RIF
A study testing Hysterocopic metroplasty in people with Recurrent Implantation Failure and T-Shaped Uterus, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
In recent years with the continuous improvement of ART technology, it has brought new hope to infertile couples, however more than half of the patients still experience multiple transfer failures. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Recurrent Implantation Failure, T-Shaped Uterus
- What is being tested?
- Hysterocopic metroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- At least twice previous implantation failures
- Willing to receive further embryo transfer
Who cannot join
- Sturctural intrauterine lesions
- Severe adenomyosis
- Premature ovarian failure
- BMI > 35 kg/m^2
- Severe systemic disease or maligant tumor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 201204
About this study
Official title: Research on the Effect of Hysteroscopic Metroplasty with Cold Scissors on Reproductive Outcome in Patients with Recurrent Implantation Failure
In recent years with the continuous improvement of ART technology, it has brought new hope to infertile couples, however more than half of the patients still experience multiple transfer failures. Abnormalities in the structure of the uterine cavity are one of the main factors that lead to the failure of embryo implantation. Hysteroscopic metroplasty with cold scissors is an innovative technique of our team, in which micro-scissors are used in the procedure instead of the previous electric knife. Our previous study found that this technique has the effect of improving fertility outcomes in patients with T-shaped uterus.
Based on the previous study, this study is an open randomized controlled trial to include patients with more than 2 or more ART implantation failures. For the first time, cold knife hysteroscopic hysterectomy was used to treat patients with cryptic uterine stenosis in patients with repeated RIF implantation failures to assess the clinical efficacy of the technique and to investigate the effect of this technique on the pregnancy outcome of reimplantation of embryos in patients with repeated ART implantation failures. Meanwhile, this project is the first to study the diagnostic value of transvaginal 3D ultrasound/MRI for the assessment of uterine cavity status in patients with RIF, with a view to exploring the value of noninvasive imaging as an alternative to invasive hysteroscopy in the clinical management of RIF. The aim of the study is to provide a reference for early diagnosis and treatment of patients with repeated ART implantation failures, and to improve the pregnancy outcome of their reimplanted embryos.
- Conditions
- Recurrent Implantation Failure, T-Shaped Uterus
- Being tested
- Hysterocopic metroplasty
- Keywords
- hysteroscopic metroplasty with cold scissiors, female infertility, recurrent implantation failure, reproductive outcome
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysterocopic metroplastyProcedure or surgery
If the uterine cavity is normal during intraoperative hysteroscopy, the operation will be finished and embryo transfer will be scheduled in 1 month after the operation; if the uterine cavity is narrowed or the uterine wall is coalesced, hysteroscopic metroplasty and IUD placement will be performed, and a second hysteroscopy with IUD retrieval will be performed after 2-month postoperative estrogen-progesterone treatment, then embryo transfer will be scheduled after 1-month estrogen-progesterone treatment.
| Study group | Role | What they receive |
|---|---|---|
| Direct Embryo Transfer | No intervention | Patients in this group receive embryo transfer without hysteroscopy |
| Hysteroscopy | Experimental | Patients in this group receive hysteroscopic examination. If T-shaped uterus is diagnosed during the operation, hysteroscopic metroplasty will be performed. Receives: Procedure: Hysterocopic metroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Proportion of patients whose blood β-hCG test is positive after embryo transfer
Measured: From enrollment to the 18 months after the last embryo transfer
Secondary outcomes (4)
Biochemical pregnancy rate
Proportion of patients who have elevated blood β-hCG (> 25 mIU/mL) or positive urine immunopregnancy test, but ultrasound test reveal no gestational sac.
Measured: From enrollment to the 18 months after the last embryo transfer
Clinical pregnancy rate
Proportion of patients who have fetal primitive heart tube pulsation tested with ultrasonography 4 weeks after embryo transfer.
Measured: From enrollment to the 18 months after the last embryo transfer
Fetal implantation rate
Proportion of transfered embryos which develop into intrauterine gestational sacs.
Measured: From enrollment to the 18 months after the last embryo transfer
Miscarriage rate
Proportion of patients with unintentional termination of intrauterine pregnancy at 28 gestational weeks.
Measured: From enrollment to the 18 months after the last embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Jan 2022
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847386
- Sponsor's protocol ID
- 22Y11906100
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 26 Feb 2025
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Effect of Hysteroscopic Metroplasty with Cold Scissors on Reproductive Outcome in Patients with Recurrent Implantation Failure
- ClinicalTrials.gov ID
- NCT06847386
- Acronym / sponsor ID
- 22Y11906100
- Conditions
- Recurrent Implantation Failure, T-Shaped Uterus
- Keywords
- hysteroscopic metroplasty with cold scissiors, female infertility, recurrent implantation failure, reproductive outcome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 26 Feb 2025 (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.
In recent years with the continuous improvement of ART technology, it has brought new hope to infertile couples, however more than half of the patients still experience multiple transfer failures. Abnormalities in the structure of the uterine cavity are one of the main factors that lead to the failure of embryo implantation. Hysteroscopic metroplasty with cold scissors is an innovative technique of our team, in which micro-scissors are used in the procedure instead of the previous electric knife. Our previous study found that this technique has the effect of improving fertility outcomes in patients with T-shaped uterus.
Based on the previous study, this study is an open randomized controlled trial to include patients with more than 2 or more ART implantation failures. For the first time, cold knife hysteroscopic hysterectomy was used to treat patients with cryptic uterine stenosis in patients with repeated RIF implantation failures to assess the clinical efficacy of the technique and to investigate the effect of this technique on the pregnancy outcome of reimplantation of embryos in patients with repeated ART implantation failures. Meanwhile, this project is the first to study the diagnostic value of transvaginal 3D ultrasound/MRI for the assessment of uterine cavity status in patients with RIF, with a view to exploring the value of noninvasive imaging as an alternative to invasive hysteroscopy in the clinical management of RIF. The aim of the study is to provide a reference for early diagnosis and treatment of patients with repeated ART implantation failures, and to improve the pregnancy outcome of their reimplanted embryos.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Embryo Transfer | No intervention | –Patients in this group receive embryo transfer without hysteroscopy |
| Hysteroscopy | Experimental | Procedure: Hysterocopic metroplastyPatients in this group receive hysteroscopic examination. If T-shaped uterus is diagnosed during the operation, hysteroscopic metroplasty will be performed. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- At least twice previous implantation failures
- Willing to receive further embryo transfer
Key exclusion criteria (5 listed)
- Sturctural intrauterine lesions
- Severe adenomyosis
- Premature ovarian failure
- BMI > 35 kg/m^2
- Severe systemic disease or maligant tumor
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 |
|---|---|---|
| Hysterocopic metroplastyIf the uterine cavity is normal during intraoperative hysteroscopy, the operation will be finished and embryo transfer will be scheduled in 1 month after the operation; if the uterine cavity is narrowed or the uterine wall is coalesced, hysteroscopic metroplasty and IUD placement will be performed, and a second hysteroscopy with IUD retrieval will be performed after 2-month postoperative estrogen-progesterone treatment, then embryo transfer will be scheduled after 1-month estrogen-progesterone treatment. | Procedure or surgery | Hysteroscopy |
Primary outcome
Pregnancy rate
Time frame: From enrollment to the 18 months after the last embryo transfer
Proportion of patients whose blood β-hCG test is positive after embryo transfer
4 secondary outcomes
Biochemical pregnancy rate
Time frame: From enrollment to the 18 months after the last embryo transfer
Clinical pregnancy rate
Time frame: From enrollment to the 18 months after the last embryo transfer
Fetal implantation rate
Time frame: From enrollment to the 18 months after the last embryo transfer
Miscarriage rate
Time frame: From enrollment to the 18 months after the last embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- 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.
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 Hysterocopic metroplasty in people with Recurrent Implantation Failure and T-Shaped Uterus, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
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: enrolling by invitation, as of the sponsor's last update on 26 Feb 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pregnancy rate (time frame: From enrollment to the 18 months after the last embryo transfer). 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 26 Feb 2025.