Table I.

Secondary outcomes.

Clinical	– Cumulative live birth rate after one IVF/ICSI treatment (number of live births per initiated, initiated cycle fresh and frozen ETs up to 15 months after randomization) – Ongoing pregnancy rate (positive heart action, confirmed ≥ 10 weeks after ET by TVS) – Cumulative ongoing pregnancy rate (including fresh and frozen ETs up to 15 months after randomization) – Time to pregnancy (months)
Treatment	– Follicular development (follicle size distribution at the time of hCG administration) – Total dose and duration of gonadotrophin treatment – Number of oocytes and (top-quality) embryos (morphological assessment of embryos: combining number of blastomeres and percentage of fragmentation) – Fertilization rate (number of fertilized oocytes per number of retrieved oocytes) – Implantation rate (number of embryonic sacs observed by TVS per number of transferred embryos) – Multiple pregnancy rate, miscarriage rate, ectopic pregnancy rate – Endometrial thickness (measured by TVS at the time of hCG administration) – Pain during oocyte pick up (VAS 0–10 cm) – Adverse events, complications – Side effects of GnRH agonist and continuous OC use during the first 3 months – Cancellation rate
Endometriosis	– Recurrence of endometriosis complaints within 15 months after randomization – Need for surgical/medical treatment within 15 months after randomization – Quality of life (EHP-30) – Patients’ preference of treatment and treatment-satisfaction (VAS 0–10 cm)
Cost-effectiveness and BIA	– Direct and indirect costs within 15 months after randomization (measured by the iMCQ and iPCQ validated questionnaires).
Factors to be taken into account	– Patient characteristics (age; BMI; smoking; alcohol use; hormonal treatment prior to start of study; duration until latest therapeutic surgery prior to start of study; prior surgical procedure; complete or incomplete remediation of endometriosis with prior surgery; presence of endometrioma and/or deep endometriosis on ultrasound and/or MRI; presence of adhesions on ultrasound and/or MRI and/or during previous pelvic surgery; presence of adenomyosis diagnosed conform the MUSA criteria) – Treatment characteristics (first/second/third IVF/ICSI attempt; other indications for IVF/ICSI)

IVF = in vitro fertilization; ICSI = intracytoplasmic sperm injection; EHP-30 = Endometriosis Health Profile 30; ET= embryo transfer; hCG = human chorionic gonadotrophin; TVS = transvaginal sonography; VAS = Visual Analogue Scale; BIA = budget impact analysis; iMCQ = iMTA Medical Consumption Questionnaire; iPCQ = iMTA Productivity Cost Questionnaire; iMTA = Institute for Medical Technology Assessment; MUSA = Morphological Uterus Sonographic Assessment (van den Bosch et al., 2015); OC = oral contraceptive.