Leiomyoma, UterineFINNCT04426760
Fibroids and Infertility - a Study of the Significance of Removal of Fibroids With Regard to Endometrial Receptivity
An observational study of Leiomyoma, Uterine, run by Oslo University Hospital at 1 site in Norway.
Trial summary
We aim to explore some of the molecular factors that reduce fertility for women with leiomyomas, taking into account leiomyoma location, size, number and vascularity. Tissue samples from the endometrium and leiomyomas will be obtained during the mid secretory phase before and 3-6 months after surgical excision for a… 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
- Leiomyoma, Uterine
- What is being tested?
- Transcervical resection of fibroids and Myomectomy per laparoscopy or laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2019to 15 Sep 2024
- How long will I take part?
- 2 Years
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients referred to the Department of Gynaecology at Oslo University Hospital for treatment of submucosal or intramural leiomyomas.
Who may be able to join
- Age: 18 to 40 years
- Presence of leiomyoma(s)
- Regular menstrual cycle (28 +/- 7 days)
- Having had at least 2 normal menstrual cycles after ending the treatment if previously treated with GnRH analogue
- Signed informed consent
Who cannot join
- No treatment indication (no symptoms and/or no desire for fertility)
- Contraindication for surgery
- Known endometriosis
- Known PCOS
- Untreated hydrosalpinx
- Malignancy; gynaecological or other location
Show all 11Show fewer
- Pre-malignant or malignant pap smear or endometrial biopsy
- Hormonal treatment including ulipristal acetat and levonorgestrel intrauterine device last three months before inclusion in the study
- Ongoing treatment with GnRH analogue
- Pregnancy last 3 months
- Ongoing lactation
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo
Thea F Mikkelsen, MD, 004797612934, themik@ous-hf.no
Kirsten Hald, PhD, 004795224181, UXKILD@ous-hf.no
About this study
Official title: Mechanisms of Reduced Fertility in Women With Uterine Leiomyomas
We aim to explore some of the molecular factors that reduce fertility for women with leiomyomas, taking into account leiomyoma location, size, number and vascularity. Tissue samples from the endometrium and leiomyomas will be obtained during the mid secretory phase before and 3-6 months after surgical excision for a comprehensive search for key molecular derangements.
Read the detailed description
Baseline medical information and standard questionnaire to record symptoms are collected from all participants and a gynaecological examination and a 2D and 3D vaginal ultrasonography including saline infusion sonography (SIS), if indicated, are performed. Blood samples for the biobank for extraction of germ line DNA and for identification of possible biomarkers are taken.
The women with submucosal leiomyomas will undergo hysteroscopic myomectomy and the women with intramural leiomyomas will undergo myomectomy per laparoscopy or laparotomy.
For the participants with intramural leiomyomas and the fertile/infertile controls, endometrial samples are taken with an endometrial suction curette in an outpatient setting at day 19-23 of the menstrual cycle. The endometrial sampling in the group of women with submucosal leiomyomas is being done during the hysteroscopic removal of the leiomyoma, also at day 19-23 of the menstrual cycle.
3-6 months after surgery, cycle day 19-23, endometrial samples will be taken from the women who have undergone myomectomy and ultrasound examination is being performed. The women with submucosal leiomyomas will undergo a second look hysteroscopy
- Conditions
- Leiomyoma, Uterine
- Being tested
- Transcervical resection of fibroids, Myomectomy per laparoscopy or laparotomy
- Keywords
- Infertility, Endometrial receptivity, Leiomyoma, Fibroid
- Medical subject headings
- Leiomyoma, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcervical resection of fibroidsProcedure or surgery
Transcervical resection of fibroids
Myomectomy per laparoscopy or laparotomyProcedure or surgery
Myomectomy per laparoscopy or laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Women with submucosal leiomyoma(s) | Women with submucosal leimyomas undergoing hysteroscopical removal of the leiomyoma Receives: Procedure: Transcervical resection of fibroids | |
| Women with intramural leiomyomas | Women with intramural leiomyomas undergoing myomectomy Receives: Procedure: Myomectomy per laparoscopy or laparotomy | |
| Infertility patients | Patients treated at the Department for Reproductive Medicine at the Oslo University hospital failing to conceive after 3 or more embryo transfers with good quality embryos. | |
| Fertile women | Healthy, volunteering women with proved fertility with 1 or more deliveries and no history of infertility |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOXA 10 expression
Fold change of HOXA 10 Expression 3-6 months after myomectomy compared to pre-surgery Levels
Measured: 3-6 months
Secondary outcomes (13)
Expression of other molecular markers
Fold change of other molecular markers than HOXA 10 of endometrial receptivity 3-6 months after myomectomy and compared to fertile/infertile controls
Measured: 3-6 months
Endometrial vascular pattern
VI and FI of the endometrium and subendometrial myometrium of women with leimyomas 3-6 months after myomectomy and compared to fertile/infertile controls
Measured: 3-6 months
Vascular characteristics of leiomyomas
Vascular characteristics of leiomyomas associated with endometrial changes
Measured: 3-6 months
Leiomyoma size
Leiomyomas size in centimeters associated with endometrial changes
Measured: 3-6 months
Leiomyoma location
Leiomyoma location associated with endometrial changes
Measured: 3-6 months
Genomic characteristics
Genomic characteristics of leiomyomas associated with endometrial changes
Measured: 3-6 months
Scar formation
Scar/fibrosis/adhesion formation after myomectomy; macroscopically and histologically
Measured: 3-6 months
Pregnancy
Pregnancy and deliveries within 2 years after myomectomy.
Measured: 2 years
HOXA10 in endometrium of women with leiomyomas compared to fertile/infertile controls
Difference in HOXA 10 expression in endometrium of women with leiomyomas compared to fertile/infertile controls
Measured: 3-6 months
Expression of molecular markers adjacent to the leiomyoma versus remote from the leiomyoma
Difference in expression of molecular markers in endometrium adjacent to the leiomyoma compared to endometrium remote from the leiomyoma.
Measured: 3-6 months
Partially resected leiomyomas
Alterations in molecular markers of endometrial receptivity after partially resected submucosal leiomyomas.
Measured: 3-6 months
Submucosal leiomyomas versus intramural leiomyomas
Difference in expression of molecular markers in endometrium of women with submucosal leiomyomas compared with endometrium in women with intramural leiomyomas.
Measured: 3-6 months
Biomarkers in blood
Biomarkers in blood related to leiomyomas and a possible correlation between certain biomarkers and reduced endometrial receptivity.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Mar 2019
- Primary completion15 Sep 2021 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leiomyoma, UterineStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirsten Hald, MD, PhD, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426760
- Sponsor's protocol ID
- 2017/9703
- Acronym
- FIN
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Reduced Fertility in Women With Uterine Leiomyomas
- ClinicalTrials.gov ID
- NCT04426760
- Acronym / sponsor ID
- FIN / 2017/9703
- Conditions
- Leiomyoma, Uterine
- Keywords
- Infertility, Endometrial receptivity, Leiomyoma, Fibroid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 15 Sep 2021 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 11 Jun 2020 (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.
We aim to explore some of the molecular factors that reduce fertility for women with leiomyomas, taking into account leiomyoma location, size, number and vascularity. Tissue samples from the endometrium and leiomyomas will be obtained during the mid secretory phase before and 3-6 months after surgical excision for a comprehensive search for key molecular derangements.
Detailed description
Baseline medical information and standard questionnaire to record symptoms are collected from all participants and a gynaecological examination and a 2D and 3D vaginal ultrasonography including saline infusion sonography (SIS), if indicated, are performed. Blood samples for the biobank for extraction of germ line DNA and for identification of possible biomarkers are taken.
The women with submucosal leiomyomas will undergo hysteroscopic myomectomy and the women with intramural leiomyomas will undergo myomectomy per laparoscopy or laparotomy.
For the participants with intramural leiomyomas and the fertile/infertile controls, endometrial samples are taken with an endometrial suction curette in an outpatient setting at day 19-23 of the menstrual cycle. The endometrial sampling in the group of women with submucosal leiomyomas is being done during the hysteroscopic removal of the leiomyoma, also at day 19-23 of the menstrual cycle.
3-6 months after surgery, cycle day 19-23, endometrial samples will be taken from the women who have undergone myomectomy and ultrasound examination is being performed. The women with submucosal leiomyomas will undergo a second look hysteroscopy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Women with submucosal leiomyoma(s) | – | Procedure: Transcervical resection of fibroidsWomen with submucosal leimyomas undergoing hysteroscopical removal of the leiomyoma |
| Women with intramural leiomyomas | – | Procedure: Myomectomy per laparoscopy or laparotomyWomen with intramural leiomyomas undergoing myomectomy |
| Infertility patients | – | –Patients treated at the Department for Reproductive Medicine at the Oslo University hospital failing to conceive after 3 or more embryo transfers with good quality embryos. |
| Fertile women | – | –Healthy, volunteering women with proved fertility with 1 or more deliveries and no history of infertility |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients referred to the Department of Gynaecology at Oslo University Hospital for treatment of submucosal or intramural leiomyomas.
Key inclusion criteria (5 listed)
- Age: 18 to 40 years
- Presence of leiomyoma(s)
- Regular menstrual cycle (28 +/- 7 days)
- Having had at least 2 normal menstrual cycles after ending the treatment if previously treated with GnRH analogue
- Signed informed consent
Key exclusion criteria (11 listed)
- No treatment indication (no symptoms and/or no desire for fertility)
- Contraindication for surgery
- Known endometriosis
- Known PCOS
- Untreated hydrosalpinx
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 |
|---|---|---|
| Transcervical resection of fibroidsTranscervical resection of fibroids | Procedure or surgery | Women with submucosal leiomyoma(s) |
| Myomectomy per laparoscopy or laparotomyMyomectomy per laparoscopy or laparotomy | Procedure or surgery | Women with intramural leiomyomas |
Primary outcome
HOXA 10 expression
Time frame: 3-6 months
Fold change of HOXA 10 Expression 3-6 months after myomectomy compared to pre-surgery Levels
13 secondary outcomes
Expression of other molecular markers
Time frame: 3-6 months
Endometrial vascular pattern
Time frame: 3-6 months
Vascular characteristics of leiomyomas
Time frame: 3-6 months
Leiomyoma size
Time frame: 3-6 months
Leiomyoma location
Time frame: 3-6 months
Genomic characteristics
Time frame: 3-6 months
Scar formation
Time frame: 3-6 months
Pregnancy
Time frame: 2 years
HOXA10 in endometrium of women with leiomyomas compared to fertile/infertile controls
Time frame: 3-6 months
Expression of molecular markers adjacent to the leiomyoma versus remote from the leiomyoma
Time frame: 3-6 months
Partially resected leiomyomas
Time frame: 3-6 months
Submucosal leiomyomas versus intramural leiomyomas
Time frame: 3-6 months
Biomarkers in blood
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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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.
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 Leiomyoma, Uterine, 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thea F. Mikkelsen, MD (004797612934, themik@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOXA 10 expression (time frame: 3-6 months). 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 11 Jun 2020; AzTrials last refreshed its copy on 8 Nov 2026.