Short Versus Long Protocol for IVF and IVF+ICSI (KvL)
Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to
- frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure)
- quality of life (2. outcome measure)
- live birth rate (2. outcome measure)
- gene expression profiles of granulosa and cumulus cells, and concentrations of estradiol and vascular endothelial growth factor in follicular fluid(not only compared between GnRH agonist and antagonist protocol, but also between patients with OHSS and no OHSS and patients becoming pregnant and not becoming pregnant (2. outcome measure), and
- number of oocytes removed per treatment, number of embryo transfers per treatment and number of spontaneous abortions per treatment (these three parameters are tertiary outcome measures).
In addition to the above mentioned efficacy outcome measures the safety outcome measure "frequency of known side-effects" will be compared between the two protocols.
|Infertility Ovarian Hyperstimulation Syndrome Quality of Life Live Birth||Drug: Patients receiving short protocol IVF/ICSI-treatment. Drug: Long protocol||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study|
- Frequency of Ovarian Hyperstimulation Syndrome (OHSS) [ Time Frame: 3 years ]
- Quality of life during treatment [ Time Frame: 3 years ]
- Live births [ Time Frame: 3 years ]
- Gene expression profiles of granulosa and cumulus cells [ Time Frame: 3 years ]
- Estradiol and vascular endothelial growth factor concentrations in follicular fluid. [ Time Frame: 3 years ]
|Study Start Date:||January 2009|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patients receiving short protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-antagonist (Orgalutran®: Ganirelix)
Drug: Patients receiving short protocol IVF/ICSI-treatment.
Injection s.c. Orgalutran® (Ganirelix)0.25 mg once daily from day 5 of FSH-stimulation until HCG-day
Active Comparator: 2
Patients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®: Nafarelin)
Drug: Long protocol
Patients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®:Nafarelin)
Patients: 1100 patients are randomized prospectively to either treatment. Stratification: =<36 y/>36 y, IVF/ICSI, and treatment centre.
Methods: OHSS is quantified by consecutive measurements of weight, abdominal diameter, ultrasound measurements of ascites and ovarian volume, paraclinical parameters, and by a systematic patient questionnaire. Furthermore it is registered if the patients have been hospitalized and/or have had ascites drainage performed due to OHSS. Data from the first 100 patients are used together with Golans OHSS-classification, to make a more precise definition of OHSS. This definition is applied prospectively on data from the remaining patients.
Quality of life is gauged by a questionnaire. Child birth rate is ascertained by a pregnancy response questionnaire and by obtaining data from the Danish National Birth Registry.
Statistics: The study is designed to be able to show a 50% reduction of OHSS comparing short to long protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756028
|Dronninglund Fertility Clinic|
|Dronninglund, Denmark, 9330|
|Fertility Clinic, Hvidovre Hospital|
|Hvidovre, Denmark, 2650|
|Study Chair:||Thue Bryndorf||Hvidovre University Hospital|
|Study Chair:||Helle Meinertz||Hvidovre University Hospital|
|Principal Investigator:||Peter Hornnes||Hvidovre University Hospital|