Study visits and study procedures
| Procedure | Visit 1 Screening baseline | Visit 2 Day 0 (−14/±7 days) Initiation of study treatment (triptorelin/placebo)/ gonadotoxic treatment | Treatment visits during gonadotoxic treatment (triptorelin/placebo) (0–4 additional visits for study treatment) (±7 days) | Visit 3 EoT (±1 month) End of gonadotoxic treatment (1 or 3 months after last administration of triptorelin/placebo) | Visit 4 6 months (±1 months) From EoT | Visit 5–9 1,2,3,4,5 years (±1 months) From EoT |
| Inclusion/exclusion criteria | X | X | ||||
| Informed consent | X | |||||
| Fertility preservation | X | |||||
| Demography | X | |||||
| Physical examination | X | |||||
| Vital signs | X | X | X | X | X | X |
| Medical history | X | |||||
| Randomisation | X | |||||
| Safety blood samples* | X | X | ||||
| Pregnancy test (if older than 16 and sexually active) | X | |||||
| Biochemical markers† | X | X | X | X | ||
| Bone mineral density | X | X | X‡ | |||
| Ultrasound§ | X | X | X | X | ||
| Study treatment¶ | X | X | ||||
| Questionnaire (baseline) | X | |||||
| Questionnaire (follow-up) | X | X | X | |||
| Concomitant medication | X | X | X | X | X | X |
| Adverse events (AE and SAE) | X | X | X | X | X |
*Safety blood samples taken as clinical routine during the cancer treatment are recorded in the eCRF. Safety blood samples at baseline and EoT will be assessed as part of the study.
†Research samples including AMH, follicle stimulating hormone (FSH), inhibin, estradiol and LH.
‡Only at years 1 and 5 of follow-up.
§Antral follicle counts and ovarian Doppler flow.
¶Subjects randomised to treatment GnRHa will receive intramuscular injection(s) of triptorelin, 3.75 mg/month or 11.25 mg/3 months covering the duration of the gonadotoxic chemotherapy, subjects randomised to placebo will receive intramuscular injection(s) of placebo (NaCl 0.9%).
AE, adverse events; AMH, anti-Müllerian hormone; eCRF, electronic Case Report Form; EoT, end of treatment; GnRHa, gonadotropin-releasing hormone agonists ; LH, luteinising hormone; SAE, serious adverse events.