AdenomyosisNAPPEDIIINCT02197936
Norwegian Adenomyosis Study III: Peristalsis
An observational study of Adenomyosis and Infertility, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and the role of correct peristalsis is most important for correct sperm transport towards the fallopian tubes and implantation of the embryo, thus obtaining pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adenomyosis, Infertility, Dysmenorrhea
- How many people
- 3 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2014to 1 Jan 2019
- Phase
- Observational
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women suffering from adenomyosis and healthy control group
Who may be able to join
- Premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier and have no other pathology of the uterus, regardless of clinical symptoms.
Who cannot join
- Postmenopausal women,
- Pregnant women,
- Gynaecological cancer,
- GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy,
- Endometriosis,
- Uterine fibroids
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Gynecology, Oslo University Hospital Ullevål and Rikshospital
Oslo, 0382
About this study
Official title: Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part III
Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and the role of correct peristalsis is most important for correct sperm transport towards the fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may also account for heavy menstrual bleedings and menstrual pain.
In this study, the uterine peristalsis of women with adenomyosis will be investigated. This condition is associated to heavy menstrual bleeding, menstrual pain and infertility.
Read the detailed description
The peristalsis of the non-pregnant uterus is widely investigated and the role of correct peristalsis seems to be most important for correct sperm transport towards the fallopian tubes and implantation of the embryo. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may account for dysmenorrhea and menorrhagia. The connection of impaired peristalsis and various clinical symptoms has been shown for patients with e.g. leiomyoma and endometriosis, but not for women with adenomyosis, though the concept seems to be widely accepted.
It has also been repeatedly postulated that impaired peristalsis interferes with implantation of the embryo, yet Martinez-Conejero published a trial that showed a higher incidence of miscarriage, but no effect on embryo implantation in women undergoing oocyte donation. This might either indicate that the postulated effect of peristalsis is wrong or, more likely, since this is a study in an IVF setting, that hormonal treatment with gonadotropin-releasing hormone (GnRH)-agonist could improve implantation.
It is possible to monitor peristalsis with transvaginal ultrasound and standard patterns of uterine peristalsis are defined by Jiland already in 1996.
Findings resulting from the investigations in this study may help to determine the role and extent of impaired peristalsis in women with adenomyosis and possibly give new clues on potential treatments, as well as fill a gap in today's knowledge.
- Conditions
- Adenomyosis, Infertility, Dysmenorrhea
- Keywords
- Peristalsis, ultrasound
- Medical subject headings
- Adenomyosis, Infertility, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Peristalsis adenomyosis | with adenomyosis | |
| Peristalsis control | No adenomyosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of peristaltic waves in Hz
Frequencies of peristalsis in patients with and without adenomyosis will be compared.
Measured: five minutes
Altitude of peristaltic waves in mm
The altitude of the peristaltic waves in patients with and without adenomyosis will so be compared.
Measured: five minutes
Secondary outcomes (1)
direction of uterine peristalsis: antegrade, retrograde
Dynamic motility characterization of the uterine peristalsis in women with adenomyosis.
Measured: 5 minutes, at time of ovulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Why it stopped: Study was suspended due to organisational difficulties.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Departement of Biomedical Engineering, Tel Aviv University, Tel Aviv, Israel, Helse Sor-Ost
- Responsible party
- Principal investigator, Tina Tellum, Oslo University Hospital
- Investigators
- Tina Tellum, MD, Principal investigator, Oslo University Hospital, UllevålMarit Lieng, PhD, MD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197936
- Sponsor's protocol ID
- 2014/637c
- Acronym
- NAPPEDIII
- Status last verified
- Mar 2021
- First submitted
- 17 Jul 2014
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part III
- ClinicalTrials.gov ID
- NCT02197936
- Acronym / sponsor ID
- NAPPEDIII / 2014/637c
- Conditions
- Adenomyosis, Infertility, Dysmenorrhea
- Keywords
- Peristalsis, ultrasound
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was suspended due to organisational difficulties.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Departement of Biomedical Engineering, Tel Aviv University, Tel Aviv, Israel, Helse Sor-Ost
- Study start
- Jul 2014
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 23 Jul 2014 (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.
Spontaneous contractions (peristalsis) of the non-pregnant uterus is widely investigated and the role of correct peristalsis is most important for correct sperm transport towards the fallopian tubes and implantation of the embryo, thus obtaining pregnancy. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may also account for heavy menstrual bleedings and menstrual pain.
In this study, the uterine peristalsis of women with adenomyosis will be investigated. This condition is associated to heavy menstrual bleeding, menstrual pain and infertility.
Detailed description
The peristalsis of the non-pregnant uterus is widely investigated and the role of correct peristalsis seems to be most important for correct sperm transport towards the fallopian tubes and implantation of the embryo. At the same time, an impaired uterine peristalsis is discussed to be the reason for lower pregnancy rates and may account for dysmenorrhea and menorrhagia. The connection of impaired peristalsis and various clinical symptoms has been shown for patients with e.g. leiomyoma and endometriosis, but not for women with adenomyosis, though the concept seems to be widely accepted.
It has also been repeatedly postulated that impaired peristalsis interferes with implantation of the embryo, yet Martinez-Conejero published a trial that showed a higher incidence of miscarriage, but no effect on embryo implantation in women undergoing oocyte donation. This might either indicate that the postulated effect of peristalsis is wrong or, more likely, since this is a study in an IVF setting, that hormonal treatment with gonadotropin-releasing hormone (GnRH)-agonist could improve implantation.
It is possible to monitor peristalsis with transvaginal ultrasound and standard patterns of uterine peristalsis are defined by Jiland already in 1996.
Findings resulting from the investigations in this study may help to determine the role and extent of impaired peristalsis in women with adenomyosis and possibly give new clues on potential treatments, as well as fill a gap in today's knowledge.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peristalsis adenomyosis | – | –with adenomyosis |
| Peristalsis control | – | –No adenomyosis |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women suffering from adenomyosis and healthy control group
Key inclusion criteria (1 listed)
- Premenopausal women aged 20-45 years having been diagnosed with adenomyosis earlier and have no other pathology of the uterus, regardless of clinical symptoms.
Key exclusion criteria (6 listed)
- Postmenopausal women,
- Pregnant women,
- Gynaecological cancer,
- GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy,
- Endometriosis,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of peristaltic waves in Hz
Time frame: five minutes
Frequencies of peristalsis in patients with and without adenomyosis will be compared.
Altitude of peristaltic waves in mm
Time frame: five minutes
The altitude of the peristaltic waves in patients with and without adenomyosis will so be compared.
1 secondary outcome
direction of uterine peristalsis: antegrade, retrograde
Time frame: 5 minutes, at time of ovulation
Results and safety
The study was stopped early (reason given: Study was suspended due to organisational difficulties.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
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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.
Tina Tellum, MD principal investigator
Oslo University Hospital, Ullevål
Marit Lieng, PhD, MD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis and Infertility, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 6 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 5 Mar 2021. 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 Norway. 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 was stopped early (reason given: Study was suspended due to organisational difficulties.). 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?
Frequency of peristaltic waves in Hz (time frame: five minutes). The study lists 2 primary outcomes in all. 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 5 Mar 2021.