Short Versus Long Protocol for IVF and IVF+ICSI (KvL)
Primary Purpose
Infertility, Ovarian Hyperstimulation Syndrome, Quality of Life
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Patients receiving short protocol IVF/ICSI-treatment.
Long protocol
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring OHSS, quality of life, IVF, ICSI, GnRH-agonist, GnRH-antagonist
Eligibility 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
Sites / Locations
- Dronninglund Fertility Clinic
- Fertility Clinic, Hvidovre Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Patients receiving short protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-antagonist (Orgalutran®: Ganirelix)
Patients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®: Nafarelin)
Outcomes
Primary Outcome Measures
Frequency of Ovarian Hyperstimulation Syndrome (OHSS)
Secondary Outcome Measures
Quality of life during treatment
Live births
Gene expression profiles of granulosa and cumulus cells
Estradiol and vascular endothelial growth factor concentrations in follicular fluid.
Full Information
NCT ID
NCT00756028
First Posted
September 18, 2008
Last Updated
January 12, 2016
Sponsor
Peter Hornnes, MD, DMSc
1. Study Identification
Unique Protocol Identification Number
NCT00756028
Brief Title
Short Versus Long Protocol for IVF and IVF+ICSI
Acronym
KvL
Official Title
Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Hornnes, MD, DMSc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Ovarian Hyperstimulation Syndrome, Quality of Life, Live Birth
Keywords
OHSS, quality of life, IVF, ICSI, GnRH-agonist, GnRH-antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1099 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients receiving short protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-antagonist (Orgalutran®: Ganirelix)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®: Nafarelin)
Intervention Type
Drug
Intervention Name(s)
Patients receiving short protocol IVF/ICSI-treatment.
Intervention Description
Injection s.c. Orgalutran® (Ganirelix)0.25 mg once daily from day 5 of FSH-stimulation until HCG-day
Intervention Type
Drug
Intervention Name(s)
Long protocol
Intervention Description
Patients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®:Nafarelin)
Primary Outcome Measure Information:
Title
Frequency of Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Quality of life during treatment
Time Frame
3 years
Title
Live births
Time Frame
3 years
Title
Gene expression profiles of granulosa and cumulus cells
Time Frame
3 years
Title
Estradiol and vascular endothelial growth factor concentrations in follicular fluid.
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thue Bryndorf
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helle Meinertz
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Peter Hornnes
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dronninglund Fertility Clinic
City
Dronninglund
ZIP/Postal Code
9330
Country
Denmark
Facility Name
Fertility Clinic, Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
29175067
Citation
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.
Results Reference
derived
PubMed Identifier
28130435
Citation
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.
Results Reference
derived
PubMed Identifier
27060174
Citation
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.
Results Reference
derived
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Short Versus Long Protocol for IVF and IVF+ICSI
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