Short Versus Long Protocol for IVF and IVF+ICSI

Status: Recruiting
Study State Date: January 2009
Primary Completion Date: Anticipated May 2013
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase: Phase 4

Sponsor(s):
Peter Hornnes, MD, DMSc
 
Information By: Hvidovre University Hospital
Trial Identifier: NCT00756028
Official Title: Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study

Description:  Purpose: Comparing a GnRH agonist and an antagonist protocol for IVF/ICSI with regard to 1. frequency of ovarian hyperstimulation syndrome (OHSS) (1. outcome measure) 2. quality of life (2. outcome measure) 3. live birth rate (2. outcome measure) 4. 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 5. 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.

+ Additional Objectives Detail

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.



Accepts Healthy Volunteers?: No
Enrollment: 1100 Anticipated
Minimum Age: 18 Years
Maximum Age: 39 Years
Gender(s): Female
Additional Criteria:  Inclusion Criteria: - All patients referred for infertility receiving their first IVF or IVF+ICSI treatment Exclusion Criteria: - Previous IVF or IVF+ICSI-treatment - Uterine anomalies - It is necessary to perform direct sperm aspiration from husband's/partner's testicles - Allergy to one of the intervention products - Patient is 40 years or above

Conditions:
Infertility
Quality of Life
Ovarian Hyperstimulation Syndrome
Live Birth
Interventions:
Drug: Patients receiving short protocol IVF/ICSI-treatment.
Drug: Long protocol
 
Primary Outcome Measures:
Frequency of Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame: 3 years
Safety Issue: Yes

 
Secondary Outcome Measures:
Quality of life during treatment
Time Frame: 3 years
Safety Issue: No

Live births
Time Frame: 3 years
Safety Issue: No

Gene expression profiles of granulosa and cumulus cells
Time Frame: 3 years
Safety Issue: No

Estradiol and vascular endothelial growth factor concentrations in follicular fluid.
Time Frame: 3 years
Safety Issue: No

 
Patient Groups:
Assigned Interventions:

1: Experimental
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

 
2: Active Comparator
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)

 

Contacts:
Peter Hornnes +4538622600 peter.hornnes@hvh.regionh.dk
Mette Toftager +17737914130 / +4561714130 mette.toftager@gmail.com

Investigators:
Study Chair: Helle Meinertz, Hvidovre Hospital
Principal Investigator: Peter Hornnes, Hvidovre Hospital
Study Chair: Thue Bryndorf, Hvidovre Hospital


Study Locations:
+ Show All 2 Study Locations


Denmark
Dronninglund Fertility Clinic (Recruiting)
Dronninglund, Denmark
Contact: Tine N Hansen +4598847634 

Fertility Clinic, Hvidovre Hospital (Recruiting)
Hvidovre, Denmark
Contact: Peter Hornnes +4538622600 peter.hornnes@hvh.regionh.dk

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