Clinical trial NCT02438735: Endometrioma Related Reduced Ovarian Reserve
Official title: The Effect Of The Presence Of Endometriomas On Ovarian Reserve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: ovarian endometriomas
AMH
ovarian reserve
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The decision to include a healthy control group was taken five months after starting recruitment of women with endometrioma. Only 12 women with endometriomas had been recruited until then and none of them had six month serum AMH level measured.

Since healthy controls were reluctant to undergo transvaginal ultrasound examination, antral follicle counts were not measured as another marker of ovarian reserve for healthy controls and some women in the endometrioma group.

Brief summary: Prior studies have shown surgical excision of endometriomas are associated with a decline in ovarian reserve as assessed by serum anti-Mullerian Hormone (AMH) levels. However, the natural history of serum AMH levels in the presence of untreated endometriomas are unknown. Purpose of this study is to determine whether the presence of endometriomas cause a faster decline in serum AMH levels than in healthy women over a six months period.

Detailed description: The study is a prospective cohort study. Women diagnosed with endometriomas by transvaginal or transabdominal ultrasound or MRI will be recruited from a tertiary care endometriosis clinic. Age matched healthy controls will be recruited from the staff of the same hospital. A priorly published historical group of women who underwent endometrioma excision will be a second comparator.

Eligibility criteria: Inclusion Criteria:

* Reproductive age
* Endometrioma without indication for surgery or treatment with combined contraceptive, progestin or other hormonal intervention.

Exclusion Criteria:

* Menstrual cycle irregularity
* Polycystic ovarian syndrome
* Women who were pregnant or contemplating pregnancy in the next six months
* History of ovarian surgery
* Using medication which could affect ovarian function during six months before recruitment
* Indication for surgical excision

Primary outcomes:
measure: Change in Serum Anti- mullerian hormone (AMH) level
timeFrame: at recruitment and six months later
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University Scholl of medicine
state: Turkey/bursa
Study officials:
affiliation: Uludag University School of Medicine
name: gürkan uncu
role: STUDY_DIRECTOR
References:
citation: Uncu G, Kasapoglu I, Ozerkan K, Seyhan A, Oral Yilmaztepe A, Ata B. Prospective assessment of the impact of endometriomas and their removal on ovarian reserve and determinants of the rate of decline in ovarian reserve. Hum Reprod. 2013 Aug;28(8):2140-5. doi: 10.1093/humrep/det123. Epub 2013 Apr 26.
citation: Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.