Endometrioma Per se Versus Treatment Related Reduction in Ovarian Reserve (ERROR-2 Trial) (ERROR2)

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.

Study Overview

• Status: Unknown
• Conditions: Endometrioma; Ovarian Reserve
• Intervention / Treatment: Drug: oral contraceptive pill, oral progesterone

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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Turkey
  • Turkey/bursa
    • Bursa, Turkey/bursa, Turkey
      • Recruiting
      • Uludag University Scholl of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with endometriomas

Description

Inclusion Criteria:

• Women between 18 and 40 years of age
• Who had at least one endometrioma >3 cm

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: oral contraceptive pill, oral progesterone; ovarian endometrioma cyst excision; Other Names: surgery
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	Drug: oral contraceptive pill, oral progesterone; ovarian endometrioma cyst excision; Other Names: surgery
Group 4; Patients with endometrioma who had at least one endometrioma >3 cm and who will be treated with surgery short after recruitment	Drug: oral contraceptive pill, oral progesterone; ovarian endometrioma cyst excision; Other Names: surgery
Group 5; The control group, who do not have endometrioma and any gynecological disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AMH	Change from baseline Anti müllerian hormone levels at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AFC	Change from baseline Antral follicule counts at 6 months	6 months

Collaborators and Investigators

• Sponsor: Uludag University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (ACTUAL): August 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Contraceptive Agents, Female; Progestins; Contraceptive Agents; Contraceptives, Oral; Progesterone; Contraceptives, Oral, Combined
• Other Study ID Numbers: Uludag University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No