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 and prospective cohort study

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 and prospective cohort study - COPIE trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55530

Enrollment

730

Registered

2016-12-07

Start date

2018-10-30

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

appearance of endometrial tissue outside the womb Endometriosis

Interventions

Continuous use of oral contraceptives for three months (intervention group) versus long term pituitary down-regulation with a GnRH agonist for three months (reference group) prior to IVF/ICSI.

Eligibility

Age

18 Years to 64 Years

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 for this current wish to conceive. - Signed informed consent.

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 agonist. - Patients who previously participated in this trial. - Pregnancy. - Malignancy. - non-Dutch speaking patients - Azoospermia in partner/donor

Design outcomes

Primary

Measure	Time frame
Primary outcome: live birth rate after fresh embryo transfer.	—

Secondary

Measure	Time frame
Secondary outcomes: cumulative live birth rate after one IVF/ICSI treatment cycle including fresh and frozen embryo transfers up to 12 months after start IVF/ICSI, ongoing pregnancy rate, time to pregnancy, treatment outcome parameters (like number of oocytes), adverse events, complications, recurrences, quality of life, safety, effect of GnRH agonist treatment on cognition and costs effectiveness (direct and indirect costs).	—

Measure

Time frame

Secondary outcomes: cumulative live birth rate after one IVF/ICSI treatment cycle including fresh and frozen embryo transfers up to 12 months after start IVF/ICSI, ongoing pregnancy rate, time to pregnancy, treatment outcome parameters (like number of oocytes), adverse events, complications, recurrences, quality of life, safety, effect of GnRH agonist treatment on cognition and costs effectiveness (direct and indirect costs).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)