Short Versus Long Protocol for IVF and IVF+ICSI
Information source: Hvidovre University Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility; Ovarian Hyperstimulation Syndrome; Quality of Life; Live Birth
Intervention: Patients receiving short protocol IVF/ICSI-treatment. (Drug); Long protocol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Peter Hornnes, MD, DMSc Official(s) and/or principal investigator(s):
Thue Bryndorf, Study Chair, Affiliation: Hvidovre Hospital
Helle Meinertz, Study Chair, Affiliation: Hvidovre Hospital
Peter Hornnes, Principal Investigator, Affiliation: Hvidovre Hospital
Overall contact:
Peter Hornnes, Phone: +4538622600, Email: peter.hornnes@hvh.regionh.dk
Summary
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.
Clinical Details
Official title: Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Frequency of Ovarian Hyperstimulation Syndrome (OHSS)
Secondary outcome: Quality of life during treatmentLive births Gene expression profiles of granulosa and cumulus cells Estradiol and vascular endothelial growth factor concentrations in follicular fluid.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 39 Years.
Gender(s): Female.
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
Locations and Contacts
Peter Hornnes, Phone: +4538622600, Email: peter.hornnes@hvh.regionh.dk
Dronninglund Fertility Clinic, Dronninglund 9330, Denmark; Recruiting
Tine N Hansen, Phone: +4598847634
Tine N Hansen, MD, Principal Investigator
Bjørn Pedersen, Sub-Investigator
Fertility Clinic, Hvidovre Hospital, Hvidovre 2650, Denmark; Recruiting
Peter Hornnes, Phone: +4538622600, Email: peter.hornnes@hvh.regionh.dk
Trine Holland, Phone: +4536323632, Email: trine.holland@gmail.com
Peter Hornnes, Principal Investigator
Mette Toftager, Sub-Investigator
Jeanette Bogstad, Sub-Investigator
Lisbeth Prætorius, Sub-Investigator
Mohamed Khalil, Sub-Investigator
Additional Information
Starting date: January 2009
Last updated: September 6, 2012
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