EndometriomaIMTERONCT05637073
Effect of Management of the Endometrioma on Ovarian Reserve
An observational study of Endometrioma, run by University of Valencia at 2 sites in 2 countries.
Trial summary
Investigators aimed at comparing the impact on ovarian reserve of three usual-care management options of endometrioma, laparoscopic cystectomy (LC), hormonal treatment with daily dienogest (HT), or mere ultrasound control (UC). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Endometrioma
- What is being tested?
- Dienogest and Laparoscopic cystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Mar 2023to 2 Nov 2026
- How long will I take part?
- 1 Year
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Caucasian premenopausal women between 18-39 years with the diagnosis of endometrioma, one or more, with a diameter of up to 7 cm by endovaginal ultrasound. Body mass index comprised between 17-30 Kg/m2.
Who may be able to join
- Caucasian premenopausal women between 18-39 years with the diagnosis of endometrioma, one or more, with a diameter of up to 7 cm by endovaginal ultrasound. Body mass index comprised between 17-30 Kg/m2
Who cannot join
- Previous ovarian surgery;
- Previous pathologies involving the ovary, including other ovarian tumors, polycystic ovaries, or pelvic inflammatory disease;
- Previous diagnosis of cancer treated with chemotherapy or local radiotherapy;
- Diseases affecting the endocrine system, diabetes, thyroid, hyperprolactinemia, or the immune system (lupus, Crohn,…);
- Genesic wish;
- Endometrioma >7 cm;
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- Unhealthy habits, including smoking, alcohol consumption above social level, or illicit drugs;
- Insufficient level of autonomy for unrestrictedly signing informed consent;
- Current or previous use of hormonal contraceptives, Gonadotropin-Releasing Hormone (GnRH) analogues, any drug with a known effect on endometriosis, or any drug under investigation, for what a washing up period of 6 months will be required in all cases.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Impact of the Type of Treatment of the Endometrioma on Ovarian Reserve
Investigators aimed at comparing the impact on ovarian reserve of three usual-care management options of endometrioma, laparoscopic cystectomy (LC), hormonal treatment with daily dienogest (HT), or mere ultrasound control (UC).
Ovarian reserve will be measured by the effect on the circulating levels of anti-Mullerian hormone (AMH). Secondary objectives will be effect on pelvic pain, other symptoms, sexual function, quality of life, progression in size of the endometrioma, impact on work productivity and activity impairment, and satisfaction with treatment.
Participants will be followed by up to one year.
Read the detailed description
Investigators aimed at comparing the impact on ovarian reserve of three usual-care management options of endometrioma, laparoscopic cystectomy (LC), hormonal treatment with daily dienogest (HT), or mere ultrasound control (UC).
Secondary objectives were the comparison of the effect on i) pelvic pain, including dysmenorrhea, non-menstrual pelvic pain, deep dyspareunia, or dyschezia, ii) other symptoms including menorrhagia, gastrointestinal symptoms different to dyschezia, or urinary symptoms; iii) quality of life as assessed by the EHP-30 questionnaire; iv) sexual functions, as assessed the female sexual function index (FSFI); v) progression in the size of the tumor in the case of the two non-surgical approaches; vi) impact on work productivity and activity impairment; vii) satisfaction in the patient.
A prospective assessment will be performed on a cohort of women with endometrioma diagnosed by ultrasound from diagnosis for up to one year. The assignment to each management option will be performed under usual care conditions so that the selected option will result from the shared clinical decision of the clinician with the patient.
The target population will be composed of Caucasian premenopausal women between 18-39 years with the diagnosis of endometrioma, one or more, with a diameter of up to 7 cm by endovaginal ultrasound. Body mass index comprised between 17-30 Kg/m2.
Participants will be controlled at 3 months, 6 months and one year.
- Conditions
- Endometrioma
- Being tested
- Dienogest, Laparoscopic cystectomy, Control with ultrasound without other type of intervention
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DienogestDrug
Some women in the cohort will be treated with dienogest for one year after consensus with the physician
Laparoscopic cystectomyProcedure or surgery
Some women in the cohort will be treated with laparoscopic cystectomy after consensus with the physician
Control with ultrasound without other type of interventionOther
Some women in the cohort will be followed with ultrasound control, without other intervention, after consensus with the physician
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the levels of anti-Mullerian hormone
Ovarian reserve as measured by the levels of AMH
Measured: Change from baseline AMH levels at 1 year
Secondary outcomes (5)
Change of Pelvic pain
Dysmenorrhea, non-menstrual pelvic pain, deep dyspareunia, or dyschezia measured by a visual analogue scale from 0 to 5 and in which higher score means worse outcome.
Measured: Change from baseline pelvic pain at 1 year.
Change in quality of life
Assessed by the Endometriosis Health Profile-30 (EHP-30) questionnaire, in which the minimum score is 0 and the highest 150. Higher score means a worse outcome.
Measured: Change from baseline EHP-30 score at 1 year.
Change in sexual function
Assessed the female sexual function index (FSFI) questionnaire in which there are 6 questions from 0 to 5. The highest score is 30 and the lowest 0. Lower score means worse outcome.
Measured: Change from baseline FSFI score at 1 year.
Change in volume of the tumor
Measured by ultrasound, in the case of the two non-surgical approaches
Measured: Change from baseline endometrioma volume at 1 year.
Satisfaction of the patient
Satisfaction as assessed by a Likert scale in which the score is from 0 to 5 in which higher score means better outcome.
Measured: Satisfaction level measured by Likert scale at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start14 Mar 2023
- Primary completion2 Jun 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Why it stopped: After months of attempts, an insurmountable difficulty has arisen in recruiting patients at the main center, in addition to the retirement of the principal investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriomaStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Comarcal Francesc de Borja Gandía, Valencia, Spain, Hospital Universitario San Juan de Alicante, Poznan University of Medical Sciences
- Responsible party
- Principal investigator, Antonio Cano Sanchez, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637073
- Sponsor's protocol ID
- IMTERO_22
- Acronym
- IMTERO
- Status last verified
- Jul 2026
- First submitted
- 22 Oct 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Type of Treatment of the Endometrioma on Ovarian Reserve
- ClinicalTrials.gov ID
- NCT05637073
- Acronym / sponsor ID
- IMTERO / IMTERO_22
- Conditions
- Endometrioma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: After months of attempts, an insurmountable difficulty has arisen in recruiting patients at the main center, in addition to the retirement of the principal investigator.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital Comarcal Francesc de Borja Gandía, Valencia, Spain, Hospital Universitario San Juan de Alicante, Poznan University of Medical Sciences
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 2 Jun 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 5 Dec 2022 (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.
Investigators aimed at comparing the impact on ovarian reserve of three usual-care management options of endometrioma, laparoscopic cystectomy (LC), hormonal treatment with daily dienogest (HT), or mere ultrasound control (UC).
Ovarian reserve will be measured by the effect on the circulating levels of anti-Mullerian hormone (AMH). Secondary objectives will be effect on pelvic pain, other symptoms, sexual function, quality of life, progression in size of the endometrioma, impact on work productivity and activity impairment, and satisfaction with treatment.
Participants will be followed by up to one year.
Detailed description
Investigators aimed at comparing the impact on ovarian reserve of three usual-care management options of endometrioma, laparoscopic cystectomy (LC), hormonal treatment with daily dienogest (HT), or mere ultrasound control (UC).
Secondary objectives were the comparison of the effect on i) pelvic pain, including dysmenorrhea, non-menstrual pelvic pain, deep dyspareunia, or dyschezia, ii) other symptoms including menorrhagia, gastrointestinal symptoms different to dyschezia, or urinary symptoms; iii) quality of life as assessed by the EHP-30 questionnaire; iv) sexual functions, as assessed the female sexual function index (FSFI); v) progression in the size of the tumor in the case of the two non-surgical approaches; vi) impact on work productivity and activity impairment; vii) satisfaction in the patient.
A prospective assessment will be performed on a cohort of women with endometrioma diagnosed by ultrasound from diagnosis for up to one year. The assignment to each management option will be performed under usual care conditions so that the selected option will result from the shared clinical decision of the clinician with the patient.
The target population will be composed of Caucasian premenopausal women between 18-39 years with the diagnosis of endometrioma, one or more, with a diameter of up to 7 cm by endovaginal ultrasound. Body mass index comprised between 17-30 Kg/m2.
Participants will be controlled at 3 months, 6 months and one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Caucasian premenopausal women between 18-39 years with the diagnosis of endometrioma, one or more, with a diameter of up to 7 cm by endovaginal ultrasound. Body mass index comprised between 17-30 Kg/m2.
Key inclusion criteria (1 listed)
- Caucasian premenopausal women between 18-39 years with the diagnosis of endometrioma, one or more, with a diameter of up to 7 cm by endovaginal ultrasound. Body mass index comprised between 17-30 Kg/m2
Key exclusion criteria (9 listed)
- Previous ovarian surgery;
- Previous pathologies involving the ovary, including other ovarian tumors, polycystic ovaries, or pelvic inflammatory disease;
- Previous diagnosis of cancer treated with chemotherapy or local radiotherapy;
- Diseases affecting the endocrine system, diabetes, thyroid, hyperprolactinemia, or the immune system (lupus, Crohn,…);
- Genesic wish;
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 |
|---|---|---|
| DienogestSome women in the cohort will be treated with dienogest for one year after consensus with the physician | Drug | – |
| Laparoscopic cystectomySome women in the cohort will be treated with laparoscopic cystectomy after consensus with the physician | Procedure or surgery | – |
| Control with ultrasound without other type of interventionSome women in the cohort will be followed with ultrasound control, without other intervention, after consensus with the physician | Other | – |
Primary outcome
Change in the levels of anti-Mullerian hormone
Time frame: Change from baseline AMH levels at 1 year
Ovarian reserve as measured by the levels of AMH
5 secondary outcomes
Change of Pelvic pain
Time frame: Change from baseline pelvic pain at 1 year.
Change in quality of life
Time frame: Change from baseline EHP-30 score at 1 year.
Change in sexual function
Time frame: Change from baseline FSFI score at 1 year.
Change in volume of the tumor
Time frame: Change from baseline endometrioma volume at 1 year.
Satisfaction of the patient
Time frame: Satisfaction level measured by Likert scale at 1 year.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrioma, run by University of Valencia at 2 sites in 2 countries.
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 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: withdrawn, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland, Spain. 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 withdrawn before enrolling participants, so there are no results.
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?
Change in the levels of anti-Mullerian hormone (time frame: Change from baseline AMH levels at 1 year). 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 8 Jul 2026.