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

Recruiting

Conditions: appearance of endometrial tissue outside the womb
Endometriosis
10013356

Registration Number: NL-OMON55530

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 730

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

- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome: live birth rate after fresh embryo transfer. </p><br>

Secondary Outcome Measures

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