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Women born in Northern Finland during 1985-1987 fulfilling ≥2 Rotterdam criteria.

Women born in Northern Finland during 1985-1987 who are PCOM negative with no other diagnostic features of PCOS according to the Rotterdam criteria.

Terhi T Piltonen, Professor

Riikka K Arffman, PhD

The purpose of this study is to validate the anti-müllerian hormone (AMH) cut-off established and validated in the APHRODITE study, for the determination of PCOM as part of the diagnosis of PCOS, using the Elecsys AMH Plus immunoassay.

The study participants will be women born July 1985-Dec 1987 in Northern Finland; the study partially links to the Northern Finland Birth Cohort 1986. Female subjects included in this cohort will be invited to participate in the study with the aim to enroll up to 1800 subjects. Each enrolled subject will have one study visit, where the clinical data required for assessing their PCOS status will be recorded, including a gynecological examination by transvaginal ultrasound to determine polycystic ovarian morphology (PCOM) status (antral follicle count and ovarian volume). Study subjects will also have blood drawn for serum collection, where hormonal parameters relevant for PCOS will be measured. The collected serum will also be used to measure the AMH levels using the Roche Elecsys AMH test.

Subjects born in Northern Finland in July 1985- December 1987 who were assigned female at birth and currently register as females.

AMH for the Identification of PCOM in PCOS Diagnosis

Human Anti-MülleRian Hormone for Diagnosis of PCOS Study

Data will be deposited into the Arctic Biobank as part of the Northern Finland Birth Cohort 1986 data.

The performance (sensitivity and specificity) of the AMH cut-off will be calculated by comparing the AMH values to the PCOM status of the subjects based on the TVUS findings (AFC \& Ovarian volume).

PCOS is diagnosed based on the Rotterdam Criteria with the presence of at least two of the following symptoms: 1. Polycystic ovarian morphology by trans-vaginal ultrasound (\>=20 follicles in either ovary or ovarian volume \>= 10 mL), 2. Hyperandrogenism, either clinical or biochemical (testosterone/free androgen index) and 3. oligo-amenorrhea (\< 8 menstruations/year).

Roche Diagnostics GmbH

Oulu University Hospital

Skin and Connective Tissue Diseases

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Leiomyoma

Myofibroma

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Pelvic Pain

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Neoplasms by Histologic Type

Uterine Diseases

Hormone Antagonists

Patients with uterine myoma, endometriosis, fibromatous uterus, chronic pelvic pain in list for surgery are usually pharmacologically treated by administration of GnRHa, 11.25 mg at 21° day of the menstrual cycle and repeated after 3 months to reduce pain symptoms, menstrual blood loss, uterine or fibroids vascularization and size, during the months spent on surgery waiting list.

Patients enrolled will be subjected to valuation of ovarian reserve: specifically, serum levels of AMH and antral follicle count (AFC) between 1 and 4 days of the menstrual cycle will be measured at study entry and at 1, 3 and 6 months after the administration of the first vial of GnRH-a

Patients with uterine myoma, endometriosis, fibromatous uterus, chronic pelvic pain in list for laparoscopic surgery or laparotomy are usually pharmacologically treated by administration of GnRHa, 11.25 mg at 21° day of the menstrual cycle and repeated after 3 months. This treatment is part of our preoperative routine in order to reduce pain symptoms, menstrual blood loss, uterine or fibroids vascularization and size, during the months spent on surgery waiting list.

Patients who will satisfy inclusion and exclusion criteria will be enrolled in this study protocol and will be subjected to valuation of ovarian reserve: specifically, serum levels of AMH and antral follicle count (AFC) between first and fourth days of the menstrual cycle will be measured.

GnRH analogue

Fulvio Zullo

To evaluate the variation of AMH levels in women undergoing treatment with GnRHa, and to assess whether this variation correlates with changes in the antral and pre-antral follicle ultrasonographic count (AFC).

The anti Mullerian hormone (AMH) is a glycoprotein produced by granulosa cells of antral and preantral ovarian follicles.

Several studies have shown that the AMH levels provide a reliable indication of the size of the growing follicles pool (1). AMH is now commonly used as a biomarker for improving the ovarian reserve in women of reproductive age because it is related with outcomes of assisted reproduction cycles, chances of pregnancy and distance from menopause (2-4).

For several years GnRH agonists have been used for the purpose of preserving fertility in the course of chemotherapy in young women with cancer (5). Their effectiveness, however, isn't 100% and there is the need to monitor the ovarian reserve in the course of treatment in these young women. With the administration of GnRHa, the FSH levels (the most used hormone for improve the ovarian reserve, although it is less reliable and less manageable because of its intra-cyclic variations) cannot be used to measure the residual ovarian function due to the physiological reduction of gonadotropins induced by the treatment. AMH levels, conversely, are relatively stable both during the menstrual cycle (6) and during administration of the contraceptive pill (7,8), suggesting the gonadotrophin independence of this molecule. AMH could therefore be a useful biomarker of ovarian reserve in the course of GnRHa treatment.

The use of GnRHa for fertility preservation during chemotherapy is controversial because of inconclusive outcome data on fertility (9) and because the mechanism by which GnRHa may act to preserve fertility is unknown. The major function of GnRHa is to suppress the production of pituitary gonadotrophins, acting indirectly on the ovarian follicles, not exposing growing follicles to the toxicity of chemotherapy and thus protecting the future ovarian function.

Determine the effect of GnRHa on AMH serum level is an essential step to determine both the effectiveness of the treatment in terms of preservation of fertility and the reliability of this marker for ovarian reserve in cancer patients treated with GnRHa. Up to now, the published studies have shown extremely contrasting data. Considered that GnRHa is largely used in non-oncological patients for preoperative pharmacological preparation in various benign gynecological conditions, it is possible to exploit the high number of patients with these characteristics for the non-invasive assessment of analogue effect on the AMH levels.

AMH Levels Change During Treatment With GnRh Agonist

AMH Levels Change During Treatment With GnRh Agonist: A Prospective Observational Study.

University Magna Graecia

Full Professor Obstetric Gynecology

Pathological Conditions, Anatomical

The main objective is to evaluate the ovarian reserve after laparoscopic cystectomy.

The secondary objective is the analysis of predictors of change in the ovarian reserve after surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AMH for the Identification of PCOM in PCOS Diagnosis	NCT05527353	Polycystic Ovar...		32 Years - 37 Years	Oulu University Hospital
AMH for the Identification of PCOM in PCOS Diagnosis	NCT05527353	Polycystic Ovar...		32 Years - 37 Years	Oulu University Hospital
AMH Levels Change During Treatment With GnRh Agonist	NCT02086279	Uterine Fibroid... Endometriosis Endometriosis o... Pelvic Pain	GnRH analogue	18 Years - 45 Years	University Magna Graecia
AMH Levels Change During Treatment With GnRh Agonist	NCT02086279	Uterine Fibroid... Endometriosis Endometriosis o... Pelvic Pain	GnRH analogue	18 Years - 45 Years	University Magna Graecia
The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve	NCT02852447	Antimullerian H... Ovarian Cysts Antral Follicle...		15 Years - 40 Years	Corporacion Parc Tauli

Spots Global Cancer Trial Database for antral follicle count