Continuous Oral contraceptives versus Lucrin before IVF/ICSI in Endometriosis
- Conditions
- 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.Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2016-004545-91-NL
- Lead Sponsor
- VU University Medical Center, department of reproductive Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 330
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method