Short Versus Long Protocol for IVF and IVF+ICSI (KvL)
This study is currently recruiting participants.
Verified September 2012 by Hvidovre University Hospital
Sponsor:
Peter Hornnes, MD, DMSc
Information provided by (Responsible Party):
Peter Hornnes, MD, DMSc, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00756028
First received: September 18, 2008
Last updated: September 6, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility Ovarian Hyperstimulation Syndrome Quality of Life Live Birth |
Drug: Patients receiving short protocol IVF/ICSI-treatment. Drug: Long protocol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study |
Resource links provided by NLM:
Further study details as provided by Hvidovre University Hospital:
Primary Outcome Measures:
- Frequency of Ovarian Hyperstimulation Syndrome (OHSS) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Quality of life during treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Live births [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Gene expression profiles of granulosa and cumulus cells [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Estradiol and vascular endothelial growth factor concentrations in follicular fluid. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1100 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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)
|
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| Ages Eligible for Study: | 18 Years to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756028
Contacts
| Contact: Peter Hornnes | +4538622600 | peter.hornnes@hvh.regionh.dk |
| Contact: Mette Toftager | +17737914130 / +4561714130 | mette.toftager@gmail.com |
Locations
| Denmark | |
| Dronninglund Fertility Clinic | Recruiting |
| Dronninglund, Denmark, 9330 | |
| Contact: Tine N Hansen +4598847634 | |
| Principal Investigator: Tine N Hansen, MD | |
| Sub-Investigator: Bjørn Pedersen | |
| Fertility Clinic, Hvidovre Hospital | Recruiting |
| Hvidovre, Denmark, 2650 | |
| Contact: Peter Hornnes +4538622600 peter.hornnes@hvh.regionh.dk | |
| Contact: Trine Holland +4536323632 trine.holland@gmail.com | |
| Principal Investigator: Peter Hornnes | |
| Sub-Investigator: Mette Toftager | |
| Sub-Investigator: Jeanette Bogstad | |
| Sub-Investigator: Lisbeth Prætorius | |
| Sub-Investigator: Mohamed Khalil | |
Sponsors and Collaborators
Peter Hornnes, MD, DMSc
Investigators
| Study Chair: | Thue Bryndorf | Hvidovre Hospital |
| Study Chair: | Helle Meinertz | Hvidovre Hospital |
| Principal Investigator: | Peter Hornnes | Hvidovre Hospital |
More Information
No publications provided
| Responsible Party: | Peter Hornnes, MD, DMSc, MD, DMSc, Hvidovre University Hospital |
| ClinicalTrials.gov Identifier: | NCT00756028 History of Changes |
| Other Study ID Numbers: | KvL |
| Study First Received: | September 18, 2008 |
| Last Updated: | September 6, 2012 |
| Health Authority: | Denmark: Danish Medicines Agency Denmark: Danish Dataprotection Agency |
Keywords provided by Hvidovre University Hospital:
|
OHSS quality of life IVF |
ICSI GnRH-agonist GnRH-antagonist |
Additional relevant MeSH terms:
|
Infertility Ovarian Hyperstimulation Syndrome Genital Diseases, Male Genital Diseases, Female Ovarian Diseases Adnexal Diseases |
Gonadal Disorders Endocrine System Diseases Deslorelin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013