OPTIMisation of cost effectiveness through Individualised FSH Stimulation dosages for IVF Treatment: A randomised trial.
Completed
- Conditions
- IVF/ICSIInfertilityOvarian reserve testAntral follicle count (AFC)Individualized FSH regimen
- Registration Number
- NL-OMON27790
- Lead Sponsor
- MC Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1500
Inclusion Criteria
1. Regular indication for IVF or IVF-ICSI;
2. Female age < 44 years;
Exclusion Criteria
1. Oocyte donation;
2. Medical contra indication for pregnancy or IVF treatment;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Ongoing pregnancy resulting in live birth within 18 months after randomisation. These pregnancies can be obtained in treatment cycles with fresh embryos, as well as in SUBSEQUENT CRYO/THAW CYCLES after completion of any fresh stimulation cycle. Spontaneous pregnancies between treatment cycles will also be taken into account;<br /><br>2. Costs of treatment: Direct medical costs, direct non-medical costs and indirect costs.
- Secondary Outcome Measures
Name Time Method 1. Number of oocytes; <br /><br>2. Poor response (less than 5 oocytes at retrieval or cancellation due to insufficient follicle growth, i.e. less than 2 dominant follicles sized more than 12 mm growing);<br>3. Hyper response (more than 15 oocytes at retrieval or cancellation due to excessive response, i.e. > 20 follicles sized > 12 mm with an estradiol above 11.700 pmol/L OR > 30 follicles sized > 12 mm growing);<br>4. OHSS grade 2 or 3;<br>5. Cycle cancellation for hyper and poor response, multiple pregnancy, total IU of FSH applied per stimulation cycle, number of cycles needed per live birth, prevalence of abnormal ORT in subfertile women.