SubfertilityNCT01743391
Hysteroscopy Before in Vitro Fertilization - Does it Improve the Outcome?
A study testing Office-hysteroscopy with biopsy in people with Subfertility and Infertility, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
By randomizing sub-fertile women to either control or office-hysteroscopy in the circle prior to IVF or ICSI (intracytoplasmatic sperm injection ) treatment, we aim to enlighten whether hysteroscopy with endometrial biopsy increases pregnancy rates in the intervention group. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Subfertility, Infertility
- What is being tested?
- Office-hysteroscopy with biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jun 2018
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women submitted to IVF or ISCI treatment
- Age > 18 years
- Women able to read, speak and understand Danish
- Written consent
Who cannot join
- Intrauterine abnormalities
- Infection
- BMI > 35
- Known intrauterine cause to the infertile condition
- Abuse of alcohol or drugs
- Untreated medical condition
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hvidovre Hospital, Department of Gynecology and Obstetrics
Copenhagen, Hvidovre, 2650
About this study
By randomizing sub-fertile women to either control or office-hysteroscopy in the circle prior to IVF or ICSI (intracytoplasmatic sperm injection
) treatment, we aim to enlighten whether hysteroscopy with endometrial biopsy increases pregnancy rates in the intervention group.
Read the detailed description
Background A tenth of a population in Denmark today is the result of assisted fertility, including IVF and ICSI. In roughly 40 % of these subfertile women the reason is unknown. Standard initial procedures include transvaginal ultrasonography, with or without saline infusion to detect intrauterine abnormalities that might explain the infertile condition. The golden standard to detect intrauterine abnormalities is hysteroscopy. Such abnormalities can be detected in a fourth of this population. Earlier studies indicate that the hysteroscopy alone - without correcting any abnormalities, affects IVF/ISCI outcome positively.
Aim By randomizing patients referred to the fertility clinic to ±office-hysteroscopy in circle prior to IVF/ISCI, we aim to enlighten whether mini-hysteroscopy with endometrial biopsy will increase the fertility by looking at pregnancy rates as our main outcome.
Method Women signed up for second IVF/ISCI treatment will be recruited, after signed consent they are randomized to either office-hysteroscopy or nothing before standard treatment in the fertility clinic.
Mini-hysteroscopy is a standard procedure in our gynecological outpatient clinic. The procedure is done without any anesthetics. Only women with normal intrauterine conditions will be enrolled in this protocol.
When the fertility clinic has a positive serum-HCG (human chorionic gonadotropin
) and a positive transvaginal sonography, pregnancy is confirmed. If negative serum-HCG, negative pregnancy will be registered.
- Conditions
- Subfertility, Infertility
- Being tested
- Office-hysteroscopy with biopsy
- Keywords
- IVF treatment, Office-hysteroscopy, Endometrial biopsy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office-hysteroscopy with biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard treatment |
| Intervention | Experimental | Office-hysteroscopy with endometrial biopsy before standard treatment Receives: Procedure: Office-hysteroscopy with biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rates
Positive serum HCG and transvaginal ultrasonography, alternatively negative serum HCG and negative outcome will be registrated. After 300 women have been included final outcome will be evaluated.
Measured: individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2018
- Study completionJun 2018
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 SubfertilityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Holbaek Sygehus
- Responsible party
- Principal investigator, Kristine Juul Hare, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743391
- Sponsor's protocol ID
- H-4-2012-158
- Status last verified
- Mar 2022
- First submitted
- 2 Dec 2012
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berntsen S, Hare KJ, Lossl K, Bogstad J, Palmo J, Praetorius L, Zedeler A, Pinborg A. Endometrial scratch injury with office hysteroscopy before IVF/ICSI: A randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:112-117. doi: 10.1016/j.ejogrb.2020.06.034. Epub 2020 Jun 17.
PubMed 32593936
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopy Before in Vitro Fertilization - Does it Improve the Outcome?
- ClinicalTrials.gov ID
- NCT01743391
- Acronym / sponsor ID
- H-4-2012-158
- Conditions
- Subfertility, Infertility
- Keywords
- IVF treatment, Office-hysteroscopy, Endometrial biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Holbaek Sygehus
- Study start
- Jan 2013
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 6 Dec 2012 (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.
By randomizing sub-fertile women to either control or office-hysteroscopy in the circle prior to IVF or ICSI (intracytoplasmatic sperm injection
) treatment, we aim to enlighten whether hysteroscopy with endometrial biopsy increases pregnancy rates in the intervention group.
Detailed description
Background A tenth of a population in Denmark today is the result of assisted fertility, including IVF and ICSI. In roughly 40 % of these subfertile women the reason is unknown. Standard initial procedures include transvaginal ultrasonography, with or without saline infusion to detect intrauterine abnormalities that might explain the infertile condition. The golden standard to detect intrauterine abnormalities is hysteroscopy. Such abnormalities can be detected in a fourth of this population. Earlier studies indicate that the hysteroscopy alone - without correcting any abnormalities, affects IVF/ISCI outcome positively.
Aim By randomizing patients referred to the fertility clinic to ±office-hysteroscopy in circle prior to IVF/ISCI, we aim to enlighten whether mini-hysteroscopy with endometrial biopsy will increase the fertility by looking at pregnancy rates as our main outcome.
Method Women signed up for second IVF/ISCI treatment will be recruited, after signed consent they are randomized to either office-hysteroscopy or nothing before standard treatment in the fertility clinic.
Mini-hysteroscopy is a standard procedure in our gynecological outpatient clinic. The procedure is done without any anesthetics. Only women with normal intrauterine conditions will be enrolled in this protocol.
When the fertility clinic has a positive serum-HCG (human chorionic gonadotropin
) and a positive transvaginal sonography, pregnancy is confirmed. If negative serum-HCG, negative pregnancy will be registered.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard treatment |
| Intervention | Experimental | Procedure: Office-hysteroscopy with biopsyOffice-hysteroscopy with endometrial biopsy before standard treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women submitted to IVF or ISCI treatment
- Age > 18 years
- Women able to read, speak and understand Danish
- Written consent
Key exclusion criteria (7 listed)
- Intrauterine abnormalities
- Infection
- BMI > 35
- Known intrauterine cause to the infertile condition
- Abuse of alcohol or drugs
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 |
|---|---|---|
| Office-hysteroscopy with biopsy | Procedure or surgery | Intervention |
Primary outcome
pregnancy rates
Time frame: individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years.
Positive serum HCG and transvaginal ultrasonography, alternatively negative serum HCG and negative outcome will be registrated. After 300 women have been included final outcome will be evaluated.
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 29 Mar 2022.
- Derived from this study: PubMed 32593936Berntsen S, Hare KJ, Lossl K, Bogstad J, Palmo J, Praetorius L, Zedeler A, Pinborg A. Endometrial scratch injury with office hysteroscopy before IVF/ICSI: A randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:112-117. doi: 10.1016/j.ejogrb.2020.06.034. Epub 2020 Jun 17.
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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.
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 Office-hysteroscopy with biopsy in people with Subfertility and Infertility, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 7 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 29 Mar 2022. 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 Denmark. 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?
pregnancy rates (time frame: individual outcome will be evaluated within 8 weeks after IVF treatment. Over all outcome will be evaluated after 3 years.). 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 NCT01743391, 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 29 Mar 2022.