Minor Intra-uterine AbnormalitiesPhase 2NCT00830401
The Impact of Treating Minor Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy in Unselected In Vitro Fertilization (IVF) Cases
A Phase 2 study testing Treatment of predefined abnormality by hysteroscopic surgery and Ofloxacinum/Doxycycline in people with Minor Intra-uterine Abnormalities, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This is a comparative, controlled trial to evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment. Read more about this study
- Who is it for?
- Ages Up to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Minor Intra-uterine Abnormalities
- What is being tested?
- Treatment of predefined abnormality by hysteroscopic surgery and Ofloxacinum/Doxycycline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2007to Mar 2009
- Phase
- Phase 2
- 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 Up to 36 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Normal Transvaginal Ultrasound
- No prior hysteroscopy
- Regular menstrual cycle
- Single embryo transfer
- BMI between 18 and 29
- Presence of both ovaries
- Primary or secondary infertility
- Women indicated for a first IVF/ICSI cycle
Who cannot join
- Recurrent miscarriage
- Prior hysteroscopic treatments
- Endometriosis > AFS Stage II
- Meno-metrorrhagia (defined as any intermenstrual loss of blood)
- Submucosal/Intracavitary Fibroids taking more than 50% of the cavity
- Hydrosalpinx
Show all 9Show fewer
- FSH/LH > 12IU/L on day 3
- Polyps taking more than 50% of the cavity
- Severe adhesions > grade II
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Controlled Trial of Treatment of Minor Unexpected Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy Screening in Women Indicated for IVF
This is a comparative, controlled trial to evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.
Read the detailed description
Introduction- Implantation failure after IVF may be due to endometrial function, embryo quality or a combination of both. The prevalence of minor intracavitary pathology in cases with an apparent normal transvaginal sonography (TVS) observed at hysteroscopy has been recorded to be 25-40%. Treatment of such pathology prior to initiating IVF/ICSI has been advocated without high-quality evidence.
Objective- To evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.
Material \& methods- Patients, indicated for their first IVF/ICSI treatment cycle at the UMC Utrecht and AZ-VUB Brussels, initially underwent TVS. In case of a normal TVS these patients were scheduled for hysteroscopy in the early-mid follicular phase of the cycle, one to three months before starting IVF/ICSI treatment. Vaginoscopic hysteroscopy was performed in an ambulatory office setting. During the hysteroscopy a biopsy was taken, to diagnose chronic endometrial inflammation. In case of finding a predefined intra uterine abnormality (polyp, myoma, adhesion, septum, endometrial inflammation) randomisation took place if prior to hysteroscopy informed consent had been obtained for endoscopy treatment versus no treatment. Shortly after the hysteroscopy, IVF/ICSI treatment was initiated and outcome during one year treatment period will be recorded.
- Conditions
- Minor Intra-uterine Abnormalities
- Being tested
- Treatment of predefined abnormality by hysteroscopic surgery, Ofloxacinum/Doxycycline
- Keywords
- intra-uterine abnormalities, intracavitary pathology, hysteroscopy, IVF, ICSI, polyp, myoma, adhesion, septum, endometritis
- Medical subject headings
- Polyps, Myoma, Tissue Adhesions, Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of predefined abnormality by hysteroscopic surgeryProcedure or surgery
- Polyp resection with Hysteroscopic scissors or Versapoint
- Resection of myoma with Resectoscope Storz or Versapoint
- Septum resection with Resectoscope Storz or Versapoint
- Resection of adhesions with Hysteroscopic scissors or Versapoint
Ofloxacinum/DoxycyclineDrug
Treatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | One or more of the predefined minor intra-uterine abnormalities have been detected, but not treated during hysteroscopy. |
| 2 | Active comparator | One or more of the predefined minor intra-uterine abnormalities have been detected and treated during hysteroscopy. Receives: Procedure: Treatment of predefined abnormality by hysteroscopic surgery; Drug: Ofloxacinum/Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative implantation rate
Measured: One year
Secondary outcomes (2)
Cumulative ongoing pregnancy
Measured: One year
Presence of minor uterine abnormalities
Measured: At hysteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJun 2007
- Primary completionNov 2008
- Study completionMar 2009
Why it stopped: Abnormality prevalence revealed to be much lower than expected.
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 Minor Intra-uterine AbnormalitiesStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Responsible party
- Principal investigator, Bart CJM Fauser, UMC Utrecht
- Investigators
- Bart CJM Fauser, Prof. dr., Study chair, UMC UtrechtPaul Devroey, Prof. dr., Study chair, Universitair Ziekenhuis BrusselFrank JM Broekmans, Dr., Study director, UMC UtrechtHuman M Fatemi, Dr., Study director, Universitair Ziekenhuis BrusselJenneke C Kasius, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830401
- Sponsor's protocol ID
- TEAtrial
- Status last verified
- Jun 2015
- First submitted
- 26 Jan 2009
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Smit JG, Kasius JC, Eijkemans MJ, Veersema S, Fatemi HM, Santbrink van EJ, Campo R, Broekmans FJ. The international agreement study on the diagnosis of the septate uterus at office hysteroscopy in infertile patients. Fertil Steril. 2013 Jun;99(7):2108-13.e2. doi: 10.1016/j.fertnstert.2013.02.027. Epub 2013 Mar 13.
PubMed 23499151
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Controlled Trial of Treatment of Minor Unexpected Uterine Cavity Abnormalities Diagnosed by Office Hysteroscopy Screening in Women Indicated for IVF
- ClinicalTrials.gov ID
- NCT00830401
- Acronym / sponsor ID
- TEAtrial
- Conditions
- Minor Intra-uterine Abnormalities
- Keywords
- intra-uterine abnormalities, intracavitary pathology, hysteroscopy, IVF, ICSI, polyp, myoma, adhesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Abnormality prevalence revealed to be much lower than expected.
- Enrolment
- 700 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Universitair Ziekenhuis Brussel
- Study start
- Jun 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Jan 2009 (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.
This is a comparative, controlled trial to evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.
Detailed description
Introduction- Implantation failure after IVF may be due to endometrial function, embryo quality or a combination of both. The prevalence of minor intracavitary pathology in cases with an apparent normal transvaginal sonography (TVS) observed at hysteroscopy has been recorded to be 25-40%. Treatment of such pathology prior to initiating IVF/ICSI has been advocated without high-quality evidence.
Objective- To evaluate the impact of treating undetected, asymptomatic, predefined minor uterine cavity abnormalities on the success of IVF treatment.
Material \& methods- Patients, indicated for their first IVF/ICSI treatment cycle at the UMC Utrecht and AZ-VUB Brussels, initially underwent TVS. In case of a normal TVS these patients were scheduled for hysteroscopy in the early-mid follicular phase of the cycle, one to three months before starting IVF/ICSI treatment. Vaginoscopic hysteroscopy was performed in an ambulatory office setting. During the hysteroscopy a biopsy was taken, to diagnose chronic endometrial inflammation. In case of finding a predefined intra uterine abnormality (polyp, myoma, adhesion, septum, endometrial inflammation) randomisation took place if prior to hysteroscopy informed consent had been obtained for endoscopy treatment versus no treatment. Shortly after the hysteroscopy, IVF/ICSI treatment was initiated and outcome during one year treatment period will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –One or more of the predefined minor intra-uterine abnormalities have been detected, but not treated during hysteroscopy. |
| 2 | Active comparator | Procedure: Treatment of predefined abnormality by hysteroscopic surgery, Drug: Ofloxacinum/DoxycyclineOne or more of the predefined minor intra-uterine abnormalities have been detected and treated during hysteroscopy. |
Who may qualify
- Ages
- Up to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Normal Transvaginal Ultrasound
- No prior hysteroscopy
- Regular menstrual cycle
- Single embryo transfer
- BMI between 18 and 29
Key exclusion criteria (9 listed)
- Recurrent miscarriage
- Prior hysteroscopic treatments
- Endometriosis > AFS Stage II
- Meno-metrorrhagia (defined as any intermenstrual loss of blood)
- Submucosal/Intracavitary Fibroids taking more than 50% of the cavity
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 |
|---|---|---|
| Treatment of predefined abnormality by hysteroscopic surgery* Polyp resection with Hysteroscopic scissors or Versapoint * Resection of myoma with Resectoscope Storz or Versapoint * Septum resection with Resectoscope Storz or Versapoint * Resection of adhesions with Hysteroscopic scissors or Versapoint | Procedure or surgery | 2 |
| Ofloxacinum/DoxycyclineTreatment of endometrial inflammation: Ofloxacinum 400mg/day or Doxycyline 2x100mg on day one, followed by 100mg/day during 8 days. | Drug | 2 |
Primary outcome
Cumulative implantation rate
Time frame: One year
2 secondary outcomes
Cumulative ongoing pregnancy
Time frame: One year
Presence of minor uterine abnormalities
Time frame: At hysteroscopy
Results and safety
The study was stopped early (reason given: Abnormality prevalence revealed to be much lower than expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Derived from this study: PubMed 23499151Smit JG, Kasius JC, Eijkemans MJ, Veersema S, Fatemi HM, Santbrink van EJ, Campo R, Broekmans FJ. The international agreement study on the diagnosis of the septate uterus at office hysteroscopy in infertile patients. Fertil Steril. 2013 Jun;99(7):2108-13.e2. doi: 10.1016/j.fertnstert.2013.02.027. Epub 2013 Mar 13.
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.
Bart CJM Fauser, Prof. dr. study chair
UMC Utrecht
Paul Devroey, Prof. dr. study chair
Universitair Ziekenhuis Brussel
Frank JM Broekmans, Dr. study director
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment of predefined abnormality by hysteroscopic surgery and Ofloxacinum/Doxycycline in people with Minor Intra-uterine Abnormalities, run by UMC Utrecht at 1 site in Netherlands.
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 8 inclusion and 9 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: stopped early, as of the sponsor's last update on 4 Jun 2015. 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 Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Abnormality prevalence revealed to be much lower than expected.). Results are not available in the source record.
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?
Cumulative implantation rate (time frame: One year). 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 NCT00830401, 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 4 Jun 2015.