Table 2

Primary and secondary objectives

Primary objective
	To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without GnRHa by determination of the anti-Müllerian hormone (AMH) at 12 months after end of gonadotoxic treatment (EoT) in women with breast cancer.
Secondary objectives
Key secondary objective	To estimate the changes in ovarian reserve following chemotherapy for treatment of cancer with or without GnRHa by determination of the AMH at 12 months after EoT in women with acute leukemias, lymphomas and sarcomas.
Secondary objectives (to be evaluated at EoT, 6, 12 months after EoT and continuously during follow-up years 2, 3, 4, 5 after EoT)	To estimate the changes in ovarian reserve with or without GnRHa by determination of the antral follicle counts (AFC) in women with breast cancer.
	To estimate the changes in ovarian reserve with or without GnRHa by determination of the AFC in women with acute leukemias, lymphomas and sarcomas.
	To estimate the changes in ovarian reserve with or without GnRHa by longitudinal observation of AMH levels in women with breast cancer.
	To estimate the changes in ovarian reserve with or without GnRHa by longitudinal observation of AMH levels in women with acute leukemias, lymphomas and sarcomas.
	To compare the proportion of females with or without GnRHa that develops ovarian insufficiency by determination of follicle stimulating hormone (FSH), inhibin and estradiol at standardised timepoints.
	To investigate the impact of body mass index (BMI), use of contraceptives and endocrine adjuvant therapy in changes of ovarian reserve with or without GnRHa by longitudinal observation of AMH levels, FSH, inhibin and estradiol at standardised timepoints.
	To investigate the effect of GnRHa on ovarian blood supply.
	To estimate the proportion of females with or without GnRHa that develop amenorrhoea (no menstruations).
	To investigate fertility and childbirth after cancer treatment in women with or without GnRHa who attempt pregnancy during follow-up.
	To determine health-related quality of life (QoL) with or without GnRHa during chemotherapy and after cancer treatment.
	To study development of comorbidities during follow-up and bone mineral density after completion of cancer treatment with or without GnRHa.
	To estimate disease-specific oncologic outcomes, recurrence rate, overall survival and disease-free survival with or without GnRHa.

GnRHa, gonadotropin-releasing hormone agonists.