Short Versus Long Protocol for IVF and IVF+ICSI (KvL)
Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Dronninglund, Denmark, 9330
- Dronninglund Fertility Clinic
-
Hvidovre, Denmark, 2650
- Fertility Clinic, Hvidovre Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Patients receiving short protocol IVF/ICSI-treatment.
Intervention pharmacon: GnRH-antagonist (Orgalutran®: Ganirelix)
|
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)
|
Patients receiving long protocol IVF/ICSI-treatment.
Intervention pharmacon: GnRH-agonist (Synarela®:Nafarelin)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Frequency of Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life during treatment
Time Frame: 3 years
|
3 years
|
|
Live births
Time Frame: 3 years
|
3 years
|
|
Gene expression profiles of granulosa and cumulus cells
Time Frame: 3 years
|
3 years
|
|
Estradiol and vascular endothelial growth factor concentrations in follicular fluid.
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Thue Bryndorf, Hvidovre University Hospital
- Study Chair: Helle Meinertz, Hvidovre University Hospital
- Principal Investigator: Peter Hornnes, Hvidovre University Hospital
Publications and helpful links
General Publications
- Toftager M, Sylvest R, Schmidt L, Bogstad J, Lossl K, Praetorius L, Zedeler A, Bryndorf T, Pinborg A. Quality of life and psychosocial and physical well-being among 1,023 women during their first assisted reproductive technology treatment: secondary outcome to a randomized controlled trial comparing gonadotropin-releasing hormone (GnRH) antagonist and GnRH agonist protocols. Fertil Steril. 2018 Jan;109(1):154-164. doi: 10.1016/j.fertnstert.2017.09.020. Epub 2017 Nov 23.
- Toftager M, Bogstad J, Lossl K, Praetorius L, Zedeler A, Bryndorf T, Nilas L, Pinborg A. Cumulative live birth rates after one ART cycle including all subsequent frozen-thaw cycles in 1050 women: secondary outcome of an RCT comparing GnRH-antagonist and GnRH-agonist protocols. Hum Reprod. 2017 Mar 1;32(3):556-567. doi: 10.1093/humrep/dew358.
- Toftager M, Bogstad J, Bryndorf T, Lossl K, Roskaer J, Holland T, Praetorius L, Zedeler A, Nilas L, Pinborg A. Risk of severe ovarian hyperstimulation syndrome in GnRH antagonist versus GnRH agonist protocol: RCT including 1050 first IVF/ICSI cycles. Hum Reprod. 2016 Jun;31(6):1253-64. doi: 10.1093/humrep/dew051. Epub 2016 Apr 8.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KvL
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