Endometrioma Per se Versus Treatment Related Reduction in Ovarian Reserve (ERROR-2 Trial)

Endometrioma Clinical Trial

— ERROR2  

Official title:

Endometrioma Per se Versus Treatment Related Reduction in Ovarian Reserve (ERROR-2 Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03620838
• Other study ID #: Uludag University
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2019
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Also the affect of endometrioma treatment modalities like surgery or medical on the ovarian reserve over time.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women between 18 and 40 years of age

• Who had at least one endometrioma >3 cm

Exclusion Criteria:

• Irregular periods

• Polycystic ovarian syndrome

• Pregnant patients

• Patients unable to give informed consent • Using medication which could affect ovarian function during six months before recruitment

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Ovarian Reserve

Intervention

Drug:
• oral contraceptive pill, oral progesterone
ovarian endometrioma cyst excision

Locations

Country	Name	City	State
Turkey	Uludag University Scholl of medicine	Bursa	Turkey/bursa

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMH	Change from baseline Anti müllerian hormone levels at 6 months	6 months
Secondary	AFC	Change from baseline Antral follicule counts at 6 months	6 months