Sterility, FemaleBEONENCT02522806
Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate
A study testing endometrial biopsy in people with Sterility, Female, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
In spite of all progress realized in the field of assisted reproduction the pregnancy rate by In vitro fertilization (IVF) in France, across indications, is only 23% after IVF cycle. Different causes may account for these failures and that, during all stages of pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sterility, Female
- What is being tested?
- endometrial biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2014to 10 Apr 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only first IVF
- Acceptance of protocol by patient after free and complete information and signature of consent.
- Anti-Mullerian Hormone (AMH ) greater than 1
- Member or eligible to social security system
- Availabilities for a follow up 2 or 12 months.
Who cannot join
- Known intolerance of proposed treatment
Trial locations and contacts
1 site in 1 country.
About this study
In spite of all progress realized in the field of assisted reproduction the pregnancy rate by In vitro fertilization (IVF) in France, across indications, is only 23% after IVF cycle.
Different causes may account for these failures and that, during all stages of pregnancy.
Read more
Recent studies have investigated an essential step in fecundation : uterine receptivity. Some teams have shown that a lot of immunological factors would have very significant in this step, by them possible expression in this process. Other studies looked at genes modulation, essential to implantation, with endometrium manipulation, simple, such as endometrial biopsy (EB). The last findings published on this subject, but after 2 IVF failures, are most encouraging because the pregnancy rate for these teams after just endometrial local injury (EB after 2 IVF failures) is well above their usual pregnancy rate. Some teams have focused on immunoassay of endometrial biopsy, in order to profile uterine receptivity and suggest with results, suitable treatment for each patient (ongoing study).
EB is quick, easy, make in a simple consultation and with a low cost, contrary to immunological study, which depend of ultra-specialized laboratories and therefore with an important cost.
- Conditions
- Sterility, Female
- Being tested
- endometrial biopsy
- Keywords
- Endometrial biopsy, previous ovarian hyperstimulation cycle, first IVF, antagonist protocol, clinical pregnancy rate
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endometrial biopsyProcedure or surgery
Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle. Receives: Procedure: endometrial biopsy |
| Group B | No intervention | none endometrial biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of Early pregnancy
Early pregnancy is defined by beta human chorionic gonadotropin (HCG)>100 mIU/ml defined by at least one rate of beta HCG>100 on the 3 possible dosages after embryo transfer (if first dosage negative or >100 : stop, if first dosage positive but <100 : Second dosing, if >100 or less than first result : stop, otherwise third dosing).
Endometrial biopsy (diameter : 1mm ; length : 5mm) with use a pipelle, in the second part of the cycle between J17 and J22 during cycle before IVF
Measured: Day 28
Secondary outcomes (7)
Number of middle pregnancy
Middle pregnancy is defined by an intra uterine gestation sac on echography of 5 or 6 weeks of amenorrheas.
Measured: 5 weeks of amenorrheas.
Number of late pregnancy
Late pregnancy is defined by an intra uterine evolutionary pregnancy on echography of 12 weeks of amenorrheas.
Measured: 12 weeks of amenorrheas.
number of Live birth
Measured: delivery
number of patient with endometrial chronic infection
Presence of endometrial chronic infection is measured by histopathologic analysis of biopsy
Measured: Day 22 of previous cycle of IVF
number of patient with pain
Pain is estimated by visual analogue scale note at the end of biopsy (day 22 of previous cycle of IVF)
Measured: Day 22 of previous cycle of IVF
number of patient with endometrial acute infection
An endometrial acute infection is defined by pelvic spontaneous pain and/or leucorrhoea, abnormal metrorrhagia and/or fever appearing after biopsy.
Measured: Day 24 of previous cycle of IVF
number of patient with uterine perforation
An uterine perforation is defined by intense pain at the time of the biopsy or in the days to come and/or leucorrhoea, abnormal metrorrhagia and/or fever.
Measured: Day 22 of previous cycle of IVF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start23 Sep 2014
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sterility, FemaleStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne GENOD, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522806
- Sponsor's protocol ID
- 1408062
- Other IDs
- 2014-A01003-44
- Acronym
- BEONE
- Status last verified
- Nov 2019
- First submitted
- 12 Aug 2015
- Last updated
- 18 Nov 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 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate
- ClinicalTrials.gov ID
- NCT02522806
- Acronym / sponsor ID
- BEONE / 1408062
- Conditions
- Sterility, Female
- Keywords
- Endometrial biopsy, previous ovarian hyperstimulation cycle, first IVF, antagonist protocol, clinical pregnancy rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 23 Sep 2014 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 13 Aug 2015 (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.
In spite of all progress realized in the field of assisted reproduction the pregnancy rate by In vitro fertilization (IVF) in France, across indications, is only 23% after IVF cycle.
Different causes may account for these failures and that, during all stages of pregnancy.
Recent studies have investigated an essential step in fecundation : uterine receptivity. Some teams have shown that a lot of immunological factors would have very significant in this step, by them possible expression in this process. Other studies looked at genes modulation, essential to implantation, with endometrium manipulation, simple, such as endometrial biopsy (EB). The last findings published on this subject, but after 2 IVF failures, are most encouraging because the pregnancy rate for these teams after just endometrial local injury (EB after 2 IVF failures) is well above their usual pregnancy rate. Some teams have focused on immunoassay of endometrial biopsy, in order to profile uterine receptivity and suggest with results, suitable treatment for each patient (ongoing study).
EB is quick, easy, make in a simple consultation and with a low cost, contrary to immunological study, which depend of ultra-specialized laboratories and therefore with an important cost.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: endometrial biopsyEndometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle. |
| Group B | No intervention | –none endometrial biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Only first IVF
- Acceptance of protocol by patient after free and complete information and signature of consent.
- Anti-Mullerian Hormone (AMH ) greater than 1
- Member or eligible to social security system
- Availabilities for a follow up 2 or 12 months.
Key exclusion criteria (1 listed)
- Known intolerance of proposed treatment
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 biopsyEndometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle | Procedure or surgery | Group A |
Primary outcome
number of Early pregnancy
Time frame: Day 28
Early pregnancy is defined by beta human chorionic gonadotropin (HCG)>100 mIU/ml defined by at least one rate of beta HCG>100 on the 3 possible dosages after embryo transfer (if first dosage negative or >100 : stop, if first dosage positive but <100 : Second dosing, if >100 or less than first result : stop, otherwise third dosing). Endometrial biopsy (diameter : 1mm ; length : 5mm) with use a pipelle, in the second part of the cycle between J17 and J22 during cycle before IVF
7 secondary outcomes
Number of middle pregnancy
Time frame: 5 weeks of amenorrheas.
Number of late pregnancy
Time frame: 12 weeks of amenorrheas.
number of Live birth
Time frame: delivery
number of patient with endometrial chronic infection
Time frame: Day 22 of previous cycle of IVF
number of patient with pain
Time frame: Day 22 of previous cycle of IVF
number of patient with endometrial acute infection
Time frame: Day 24 of previous cycle of IVF
number of patient with uterine perforation
Time frame: Day 22 of previous cycle of IVF
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 18 Nov 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.
Anne GENOD, MD principal investigator
CHU de SAINT-ETIENNE
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 biopsy in people with Sterility, Female, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 5 inclusion and 1 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 18 Nov 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 France. 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?
number of Early pregnancy (time frame: Day 28). 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 18 Nov 2019.