EndometriosisNCT06799754
Ovarian Reserve Following Medical Therapy in Patients With Endometriosis
An observational study of Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This study aims to investigate whether there is an effect on ovarian reserve from medical therapy for endometriosis. Although the therapeutic efficacy of medical hormone therapy on ovarian endometriosis has been proven in many scientific studies, none of these has shown an effect on ovarian reserve. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jul 2020to 18 Nov 2024
- 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
- No healthy volunteers
- Adult
Study population: Patients diagnosed with ovarian endometriosis desiring pregnancy with or without concomitant deep endometriosis
Who may be able to join
- Clinical and ultrasound diagnosis of ovarian endometriosis without indication for surgery
- Age between 18 and 40 years
- Patients desiring pregnancy
- Informed consent obtained
Who cannot join
- Endocrinological disorders (including thyroid dysfunction, hyperprolactinaemia and Cushing's syndrome)
- Previous ovarian surgery
- Suspected cyst malignancy
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
About this study
Official title: Evaluation Of The Change In Ovarian Reserve Following Medical Therapy In Patients With Endometriosis
This study aims to investigate whether there is an effect on ovarian reserve from medical therapy for endometriosis.
Although the therapeutic efficacy of medical hormone therapy on ovarian endometriosis has been proven in many scientific studies, none of these has shown an effect on ovarian reserve.
The aim of this study is to investigate whether there is a difference in ovarian reserve as measured by biochemical and ultrasound parameters before and after therapy.
Read the detailed description
Endometriosis is a benign, chronic and recurrent condition characterised by the presence of endometrial glands and stroma outside the uterine cavity. Endometriosis is most frequently localised to the ovary (17 - 44%) and is found in 5-10% of women of childbearing age. In this group of patients, quantification of the ovarian reserve by means of serological and ultrasound markers, in particular antral follicular count (AFC) and blood levels of antimullerian hormone (AMH), is essential. Recent evidence shows that medical hormone therapy, currently the first choice of treatment, affects ovarian endometriosis in terms of volumetric reduction of endometriomas and reduction of local inflammation, but little is known about its effect on ovarian reserve.
Our study therefore aims to evaluate ovarian reserve in terms of AMH and AFC in patients with ovarian endometriosis treated with medical hormone therapy after discontinuation of the latter.
In the clinical trial, patients diagnosed with ovarian endometriosis with an indication for medical therapy undergo 3 blood samples for the determination of antimullerian hormone (AMH) at the same time as 3 medical examinations as per normal care procedure.
- Conditions
- Endometriosis
- Keywords
- endometriosis, medical therapy, ovarian reserve
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian reserve in patients with ovarian endometriosis
Evaluate the ovarian reserve at ultrasound and biochemical level in patients with ovarian endometriosis treated with medical therapy
Measured: Through study completion, an average of 4 years
Secondary outcomes (3)
Follicle stimulating hormone (FSH)
Quantification of follicle stimulating hormone (FSH) levels
Measured: Through study completion, an average of 4 years
Ultrasound assessment of ovarian volume and endometriosis cyst volume
Ultrasound assessment of ovarian volume and endometriosis cyst volume
Measured: Through study completion, an average of 4 years
Ovarian reserve in patients with concomitant deep endometriosis compared to those with ovarian endometriosis alone
Evaluation of a possible difference in ovarian reserve in patients with concomitant deep endometriosis compared to those with ovarian endometriosis alone
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start19 Jul 2020
- Primary completion31 Jan 2023
- Study completion18 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato Seracchioli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799754
- Sponsor's protocol ID
- EndoAMH
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 29 Jan 2025
- 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 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Change In Ovarian Reserve Following Medical Therapy In Patients With Endometriosis
- ClinicalTrials.gov ID
- NCT06799754
- Acronym / sponsor ID
- EndoAMH
- Conditions
- Endometriosis
- Keywords
- endometriosis, medical therapy, ovarian reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 19 Jul 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 18 Nov 2024 (actual)
- First posted
- 29 Jan 2025 (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.
This study aims to investigate whether there is an effect on ovarian reserve from medical therapy for endometriosis.
Although the therapeutic efficacy of medical hormone therapy on ovarian endometriosis has been proven in many scientific studies, none of these has shown an effect on ovarian reserve.
The aim of this study is to investigate whether there is a difference in ovarian reserve as measured by biochemical and ultrasound parameters before and after therapy.
Detailed description
Endometriosis is a benign, chronic and recurrent condition characterised by the presence of endometrial glands and stroma outside the uterine cavity. Endometriosis is most frequently localised to the ovary (17 - 44%) and is found in 5-10% of women of childbearing age. In this group of patients, quantification of the ovarian reserve by means of serological and ultrasound markers, in particular antral follicular count (AFC) and blood levels of antimullerian hormone (AMH), is essential. Recent evidence shows that medical hormone therapy, currently the first choice of treatment, affects ovarian endometriosis in terms of volumetric reduction of endometriomas and reduction of local inflammation, but little is known about its effect on ovarian reserve.
Our study therefore aims to evaluate ovarian reserve in terms of AMH and AFC in patients with ovarian endometriosis treated with medical hormone therapy after discontinuation of the latter.
In the clinical trial, patients diagnosed with ovarian endometriosis with an indication for medical therapy undergo 3 blood samples for the determination of antimullerian hormone (AMH) at the same time as 3 medical examinations as per normal care procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with ovarian endometriosis desiring pregnancy with or without concomitant deep endometriosis
Key inclusion criteria (4 listed)
- Clinical and ultrasound diagnosis of ovarian endometriosis without indication for surgery
- Age between 18 and 40 years
- Patients desiring pregnancy
- Informed consent obtained
Key exclusion criteria (3 listed)
- Endocrinological disorders (including thyroid dysfunction, hyperprolactinaemia and Cushing's syndrome)
- Previous ovarian surgery
- Suspected cyst malignancy
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
Ovarian reserve in patients with ovarian endometriosis
Time frame: Through study completion, an average of 4 years
Evaluate the ovarian reserve at ultrasound and biochemical level in patients with ovarian endometriosis treated with medical therapy
3 secondary outcomes
Follicle stimulating hormone (FSH)
Time frame: Through study completion, an average of 4 years
Ultrasound assessment of ovarian volume and endometriosis cyst volume
Time frame: Through study completion, an average of 4 years
Ovarian reserve in patients with concomitant deep endometriosis compared to those with ovarian endometriosis alone
Time frame: Through study completion, an average of 4 years
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 Jan 2025.
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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.
Renato Seracchioli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Endometriosis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 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 Jan 2025. 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 Italy. 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?
Ovarian reserve in patients with ovarian endometriosis (time frame: Through study completion, an average of 4 years). 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 29 Jan 2025.