Ovarian ReserveERROR2NCT03620838
Endometrioma Per se Versus Treatment Related Reduction in Ovarian Reserve (ERROR-2 Trial)
An observational study of Ovarian Reserve and Endometrioma, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
The present multi-center study aimed to evaluate whether endometrioma-associated decline in ovarian reserve is progressive in the absence of an intervention and is greater in magnitude than the natural decline over time. 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
- Ovarian Reserve, Endometrioma
- What is being tested?
- oral contraceptive pill, oral progesterone
- Type of treatment
- Pill or oral medicine
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Sep 2020
- 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 with endometriomas
Who may be able to join
- Women between 18 and 40 years of age
- Who had at least one endometrioma >3 cm
Who cannot join
- İrregular periods
- Polycystic ovarian syndrome
- Pregnant patients
- Patients unable to give informed consent • Using medication which could affect ovarian function during six months before recruitment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uludag University Scholl of medicine
Bursa, Turkey/bursa
GÜRKAN UNCU, 0224 2952541, guncu@gurkanuncu.org
About this study
The present multi-center study aimed to evaluate whether endometrioma-associated decline in ovarian reserve is progressive in the absence of an intervention and is greater in magnitude than the natural decline over time. Also the affect of endometrioma treatment modalities like surgery or medical on the ovarian reserve over time.
Read the detailed description
While there is now a proven, prominent relationship between endometriosis and infertility, the exact mechanism of this relationship is still unclear. The relationship between endometriosis and infertility has been increasingly investigated in recent years. Infertility can be explained in those patients with advanced disease, which causes disturbance of the pelvic anatomy and will also prevent tubal passage, but the mechanism at the early stage of endometriosis has not yet been elucidated.
It has been shown that patients with endometriomas have low quantitative ovarian-reserve tests. It has also been shown with oocyte donation studies that endometriosis may be accompanied by a quantitative decrease in oocyte quality defects which may further adversely affect existing ovarian reserves. There are still debates as to whether the presence of endometriomas and the availability of endometriomas itself reduces the over-reserve, but there is no objective study or data on the subject.There are a number of studies that endometriosis may negatively affect the reserve, and also that surgery may cause further damage to the ovarian reserve.There is still lack of definite data for the affect of endometriomas per se and endometriomas treatment modalities ( Oral contraceptive pills (OCP) / progesterone or surgery)on the ovarian reserve over time. For this reason the investigators aimed to evaluate whether endometrioma-associated decline in ovarian reserve is progressive in the absence of any intervention and is greater in magnitude than the natural decline over time. Also the affect of endometrioma treatment modalities like surgery or medical on the ovarian reserve over time.
The study is planned as a prospective study including women with endometrioma diagnosed with ultrasonography and also healthy age matched women without endometriomas as the control group. Endometrioma patients will be divided to 4 subgroups of patients. The first group will be comprised women with endometriomas that who will not require any medical or surgical intervention, the second subgroup will be comprised from endometrioma patients will be treated with OCP during the study period, the third one will be comprised from endometrioma patients will be treated with progesterone and the last subgroup will be comprised from endometrioma patients who will be treated with surgical excision of the cyst. All of the patients with and without endometrioma will be evaluated with ultrasonography for Antral Follicle Count (AFC) and blood samples will be taken during recruitment for Anti-müllerian Hormone (AMH) values. Additional assessments will be done after 3 and 6 months after the first assessment. All the results will be statistically compared within the groups.
- Conditions
- Ovarian Reserve, Endometrioma
- Being tested
- oral contraceptive pill, oral progesterone
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral contraceptive pill, oral progesteroneDrug
Also called surgery
ovarian endometrioma cyst excision
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with endometrioma who had at least one endometrioma >3 cm and who will not need hormonal or surgical treatment at the time of diagnosis and who will be expectantly managed | |
| Group 2 | Patients with endometrioma who had at least one endometrioma >3 cm and who will be treated with OCP during the study period Receives: Drug: oral contraceptive pill, oral progesterone | |
| Group 3 | Patients with endometrioma who had at least one endometrioma >3 cm and who will be treated with oral progesterone during the study period Receives: Drug: oral contraceptive pill, oral progesterone | |
| Group 4 | Patients with endometrioma who had at least one endometrioma >3 cm and who will be treated with surgery short after recruitment Receives: Drug: oral contraceptive pill, oral progesterone | |
| Group 5 | The control group, who do not have endometrioma and any gynecological disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH
Change from baseline Anti müllerian hormone levels at 6 months
Measured: 6 months
Secondary outcomes (1)
AFC
Change from baseline Antral follicule counts at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Mar 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
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 Ovarian ReserveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜRKAN UNCU,PROF. MD, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620838
- Sponsor's protocol ID
- Uludag University
- Acronym
- ERROR2
- Status last verified
- Oct 2019
- First submitted
- 23 Jul 2018
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aslan K, Kasapoglu I, Kosan B, Gurbuz TB, Muzii L, Uncu G. Impact of endometrioma management strategies on ovarian reserve over the follow-up period, a prospective longitudinal study. Front Endocrinol (Lausanne). 2025 Sep 11;16:1631108. doi: 10.3389/fendo.2025.1631108. eCollection 2025.
PubMed 41019321
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrioma Per se Versus Treatment Related Reduction in Ovarian Reserve (ERROR-2 Trial)
- ClinicalTrials.gov ID
- NCT03620838
- Acronym / sponsor ID
- ERROR2 / Uludag University
- Conditions
- Ovarian Reserve, Endometrioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 8 Aug 2018 (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.
The present multi-center study aimed to evaluate whether endometrioma-associated decline in ovarian reserve is progressive in the absence of an intervention and is greater in magnitude than the natural decline over time. Also the affect of endometrioma treatment modalities like surgery or medical on the ovarian reserve over time.
Detailed description
While there is now a proven, prominent relationship between endometriosis and infertility, the exact mechanism of this relationship is still unclear. The relationship between endometriosis and infertility has been increasingly investigated in recent years. Infertility can be explained in those patients with advanced disease, which causes disturbance of the pelvic anatomy and will also prevent tubal passage, but the mechanism at the early stage of endometriosis has not yet been elucidated.
It has been shown that patients with endometriomas have low quantitative ovarian-reserve tests. It has also been shown with oocyte donation studies that endometriosis may be accompanied by a quantitative decrease in oocyte quality defects which may further adversely affect existing ovarian reserves. There are still debates as to whether the presence of endometriomas and the availability of endometriomas itself reduces the over-reserve, but there is no objective study or data on the subject.There are a number of studies that endometriosis may negatively affect the reserve, and also that surgery may cause further damage to the ovarian reserve.There is still lack of definite data for the affect of endometriomas per se and endometriomas treatment modalities ( Oral contraceptive pills (OCP) / progesterone or surgery)on the ovarian reserve over time. For this reason the investigators aimed to evaluate whether endometrioma-associated decline in ovarian reserve is progressive in the absence of any intervention and is greater in magnitude than the natural decline over time. Also the affect of endometrioma treatment modalities like surgery or medical on the ovarian reserve over time.
The study is planned as a prospective study including women with endometrioma diagnosed with ultrasonography and also healthy age matched women without endometriomas as the control group. Endometrioma patients will be divided to 4 subgroups of patients. The first group will be comprised women with endometriomas that who will not require any medical or surgical intervention, the second subgroup will be comprised from endometrioma patients will be treated with OCP during the study period, the third one will be comprised from endometrioma patients will be treated with progesterone and the last subgroup will be comprised from endometrioma patients who will be treated with surgical excision of the cyst. All of the patients with and without endometrioma will be evaluated with ultrasonography for Antral Follicle Count (AFC) and blood samples will be taken during recruitment for Anti-müllerian Hormone (AMH) values. Additional assessments will be done after 3 and 6 months after the first assessment. All the results will be statistically compared within the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with endometrioma who had at least one endometrioma >3 cm and who will not need hormonal or surgical treatment at the time of diagnosis and who will be expectantly managed |
| Group 2 | – | Drug: oral contraceptive pill, oral progesteronePatients with endometrioma who had at least one endometrioma >3 cm and who will be treated with OCP during the study period |
| Group 3 | – | Drug: oral contraceptive pill, oral progesteronePatients with endometrioma who had at least one endometrioma >3 cm and who will be treated with oral progesterone during the study period |
| Group 4 | – | Drug: oral contraceptive pill, oral progesteronePatients with endometrioma who had at least one endometrioma >3 cm and who will be treated with surgery short after recruitment |
| Group 5 | – | –The control group, who do not have endometrioma and any gynecological disorder |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with endometriomas
Key inclusion criteria (2 listed)
- Women between 18 and 40 years of age
- Who had at least one endometrioma >3 cm
Key exclusion criteria (4 listed)
- İrregular periods
- Polycystic ovarian syndrome
- Pregnant patients
- Patients unable to give informed consent • Using medication which could affect ovarian function during six months before recruitment
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 |
|---|---|---|
| oral contraceptive pill, oral progesteroneAlso: surgeryovarian endometrioma cyst excision | Drug | Group 2, Group 3, Group 4 |
Primary outcome
AMH
Time frame: 6 months
Change from baseline Anti müllerian hormone levels at 6 months
1 secondary outcome
AFC
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Derived from this study: PubMed 41019321Aslan K, Kasapoglu I, Kosan B, Gurbuz TB, Muzii L, Uncu G. Impact of endometrioma management strategies on ovarian reserve over the follow-up period, a prospective longitudinal study. Front Endocrinol (Lausanne). 2025 Sep 11;16:1631108. doi: 10.3389/fendo.2025.1631108. eCollection 2025.
- 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.
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 Ovarian Reserve and Endometrioma, run by Uludag University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 10 Oct 2019. 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 Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH (time frame: 6 months). 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 NCT03620838, 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 10 Oct 2019.