RecruitingACTRN12620001201965

Assessing change in Anti-Mullerian Hormone associated with surgical excision vs conservative management of endometrioma

Assessing change in Anti-Mullerian Hormone (ovarian reserve) associated with surgical excision vs conservative management of endometrioma: A longitudinal cohort study

Sponsor

Keryn Harlow

Enrollment

572 participants

Start Date

Oct 4, 2021

Study Type

Observational

Conditions

Endometrioma Endometriosis

Summary

Endometriomas are a type of endometriosis consisting of fluid filled benign cysts of the ovary. Endometriomas are associated with an increased risk of infertility and may require medical interventions to conceive. Management of these cysts prior to fertility treatment is controversial. On the one hand, leaving them has the potential for the cyst to get bigger and further damage ovarian tissue including eggs, as well as the very rare risks of malignancy and serious infection due to egg collection from the ovaries during fertility treatment. On the other hand, surgically removing the cyst has been shown to decrease the ovarian reserve, or the number of eggs left in the ovary and puts the patient through the risks of surgery. This study aims to investigate how the ovarian reserve changes over time in patients with endometriomas left alone compared to those patients who have endometriomas surgically removed. This will help clinicians to decide the best way to manage these cysts in the future where fertility is desired. We plan to assess the ovarian reserve using a blood test to measure anti-mullerian hormone (AMH), which is secreted by the ovary and correlates with the number of available follicles (hosting future eggs). Participants in this study will already have a management plan for their endometrioma and we will observe the change in the ovarian reserve over time by taking blood samples at 7 time points: at recruitment, 6 months post-surgery or recruitment, 12 months post- surgery or recruitment and then again at 2, 3, 4 and 5 years. These time points will be similar for both groups (cyst removal or not) to ensure comparable times between recruitment and follow-up in both study arms. The results will be available to the participants and any abnormal results will be discussed with them by the investigative team and appropriate referrals made. The initial management plan will not be affected by this study.

Eligibility

Sex: FemalesMin Age: 25 YearssMax Age: 37 Yearss

Plain Language Summary

Simplified for easier understanding

This study follows women with endometriomas (a type of ovarian cyst caused by endometriosis) over five years to see how their egg reserve — a measure of fertility potential — changes depending on whether the cysts are removed surgically or managed conservatively (left alone). Endometriomas are associated with reduced fertility, and this is an important and difficult clinical decision because surgery can itself reduce the remaining egg supply. The egg reserve is measured using a blood test for a hormone called AMH (anti-Müllerian hormone), which reflects the number of eggs remaining in the ovaries. By tracking AMH at 7 points over 5 years in both groups, this study will provide much-needed long-term data to help doctors and women make better-informed decisions about managing endometriomas when fertility is a priority. You may be eligible if you are a woman aged 25 to 37 with an ultrasound diagnosis of one or more endometriomas measuring at least 2cm, attending a gynaecology or fertility clinic in Australia or New Zealand. Women who have previously had ovarian surgery, are suspected of having cancer, do not speak English, or are planning or have had a hysterectomy are not eligible.

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Interventions

Patients with a diagnosis of one or more endometrioma will be asked to have a blood test to measure their serum anti-Mullerian hormone (AMH) and follicular stimulating hormone (FSH) levels as a marker of ovarian reserve prior to their planned intervention- either surgical excision or conservative management. The AMH and FSH will be measured at 7 time points- prior to surgery or at recruitment (for the conservative management group) and then 6 months, 1, 2, 3, 4 and 5 years following surgery or recruitment. The change in AMH and FSH over time will be assessed with a comparison between surgical or conservative management.