The research population consists of women with surgically confirmed endometriosis ASRM stage III or IV or endometrioma on transvaginal ultrasound or MRI, scheduled for an IVF/ICSI treatment.
Conditions
Interventions
Trade Name: microgynon 30 (ethinylestradiol/?levonorgestrel)
Pharmaceutical Form: Tablet
Trade Name: Lucrin (leuproreline)
Pharmaceutical Form: Powder and solution for solution for injection
Trade N
Sponsors
VU University Medical Center, department of reproductive Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with presence of endometriosis (ASRM III-IV) confirmed by previous surgery or likely to be present based on TVUS or MRI (including presence of uni- or bilateral ovarian endometrioma and deep endometriosis). - First, second or third IVF or ICSI cycle - Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 330 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients aged over 41 years (excluding patients from the day they have celebrated their 41 year birthday) - Patients with known contraindications for oral contraceptives (history of venous trombo-embolic events, positive family history for venous trombo-emblic events and/or known thrombophilic abnormalitie) or GnRH agonists - Pregnancy - Malignancy - Azoospermia in partner/donor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess non-inferiority of continuous use of oral contraceptives prior to IVF/ICSI compared to our standard “ultralong” IVF/ICSI treatment protocol of long term pituitary down-regulation with a GnRH agonist with add back therapy, with respect to live birth rate after fresh embryo transfer.;Secondary Objective: Treatment outcome parameters: Cumulative live birth rate, (cumulative) ongoing pregnancy rate, fertilization, implantation, multiple pregnancy, miscarriage, ectopic pregnancy rate, follicular development, number of oocytes and embryos, endometrial thickness, dose/duration of gonadotrophin treatment, pain, quality of life, treatment preference, treatment satisfaction. Adverse events: cancellation rate, hospitalization, ovarian hyperstimulation syndrome, growth/development of endometrioma, recurrence of endometriosis complaints. Cost effectiveness: direct and indirect costs of treatment ;Primary end point(s): - Live birth rate after fresh embryo transfer after one cycle of IVF/ICSI;Timepoint(s) of evaluation of this end point: 15 months after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Cumulative live birth rate (including fresh and frozen embryo transfers up to one year after ovum pick up has been performed) - Ongoing pregnancy rate, miscarriage rate, ectopic pregnancy rate, fertilization rate, implantation rate per embryo transferred. - Follicular development - Total dose and duration of gonadotrophin treatment - Number of oocytes and (top-quality) embryos - Number of cryo embryos - Endometrial thickness - Pain during oocyte pick up - Quality of life - Cancellation rate, adverse events, complications and recurrences - Cost-effectiveness - Patients’ treatment preference and satisfaction In the cohort study there will be no assessment of cost-effectiveness;Timepoint(s) of evaluation of this end point: T0: Time of randomisation T1: Three months after randomisation T2: Six months after randomisation T3: Nine months after randomisation T4: Twelve months after randomisation T5: Fifteen months after randomisation (end of study) | — |
Countries
Netherlands
Contacts
Public Contactdr. V. Mijatovic
VU University Medical Center, department of reproductive Medicine
Outcome results
None listed