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Continuous use of Oral contraceptives as an alternative for long term Pituitary down-regulation with a GnRH agonist prior to IVF/ICSI in Endometriosis patients: a randomised controlled trial


- candidate number26915
- NTR NumberNTR6357
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-mrt-2017
- Secondary IDsNL 59874.029.16 CCMO
- Public TitleContinuous use of Oral contraceptives as an alternative for long term Pituitary down-regulation with a GnRH agonist prior to IVF/ICSI in Endometriosis patients: a randomised controlled trial
- Scientific TitleContinuous use of Oral contraceptives as an alternative for long term Pituitary down-regulation with a GnRH agonist prior to IVF/ICSI in Endometriosis patients: a randomised controlled trial
- ACRONYMCOPIE trial
- hypothesisThe continuous use of oral contraceptives for three months prior to IVF/ICSI treatment will be non-inferior to the use of long term pituitary down-regulation with a GnRH agonist for three months prior to IVF/ICSI treatment in patients with severe endometriosis (ASRM stages III and IV).
- Healt Condition(s) or Problem(s) studiedIVF, Endometriosis, Pregnancy, Fertility
- 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).
- Scheduled for first, second or third IVF or ICSI treatment cycle
- Signed informed consent
- 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 VTE, positive family history for VTE and/or known thrombophilic abnormalities) or GnRH agonists.
- Patients who previously participated in this trial.
- Pregnancy.
- Pelvic inflammatory disease.
- Malignancy.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate1-jun-2020
- Target number of participants300
- InterventionsAfter informed consent, eligible women will be randomly allocated to the intervention group (group 1; one-phase oral contraceptive (sub 50 pill) continuously during three subsequent months (i.e.3x28days)) or the reference group (group 2; three Leuprorelin 3.75mg i.m./s.c. depot injections during three subsequent months). Tibolon 2,5mg will be given daily as add back therapy in the reference group. After three months of pre-treatment the IVF/ICSI stimulation phase will be started.
- Primary outcomeLive birth rate after fresh embryo transfer.
- Secondary outcomeSecondary outcomes are cumulative live birth rate after one IVF/ICSI treatment cycle including fresh and frozen embryo transfers up to 15 months after randomization, ongoing pregnancy rate, time to pregnancy, treatment outcome parameters (like number of oocytes), adverse events, complications, recurrences, quality of life, safety and costs effectiveness.
- TimepointsMeasurement will be performed at baseline and at three, six, nine, twelve and fifteen months after randomization.
- Trial web siteN.a.
- statusplanned
- CONTACT FOR PUBLIC QUERIESMsc Marit Lier
- CONTACT for SCIENTIFIC QUERIESMsc Marit Lier
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN.a.
- Brief summaryIn women suffering from endometriosis, long term pituitary down-regulation for three to six months prior to IVF/ICSI improves clinical pregnancy rates. However, discussion about this treatment strategy exist and uncomfortable side effects are often described. Alternatively, IVF/ICSI pre-treatment with continuously administered oral contraceptives may offer less side-effects, lower (in)direct costs as well as encouraging IVF outcomes in women with endometriosis. Until now, these two different IVF/ICSI pre-treatment strategies in women with severe endometriosis havenít been directly compared yet. Therefore we planned an open-label, parallel two-arm randomized controlled trial to show a non-inferiority of continuous use of oral contraceptives versus long term pituitary down-regulation with a GnRH agonist prior to IVF/ICSI treatment in patients with severe endometriosis (ASRM stages III and IV).
- Main changes (audit trail)
- RECORD16-mrt-2017 - 11-jun-2017


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