Short Versus Long Protocol for IVF and IVF+ICSI
KvL
Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study
1 other identifier
interventional
1,099
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2009
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 19, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 13, 2016
January 1, 2016
5.9 years
September 18, 2008
January 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of Ovarian Hyperstimulation Syndrome (OHSS)
3 years
Secondary Outcomes (4)
Quality of life during treatment
3 years
Live births
3 years
Gene expression profiles of granulosa and cumulus cells
3 years
Estradiol and vascular endothelial growth factor concentrations in follicular fluid.
3 years
Study Arms (2)
1
EXPERIMENTALPatients receiving short protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-antagonist (Orgalutran®: Ganirelix)
2
ACTIVE COMPARATORPatients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®: Nafarelin)
Interventions
Injection s.c. Orgalutran® (Ganirelix)0.25 mg once daily from day 5 of FSH-stimulation until HCG-day
Patients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®:Nafarelin)
Eligibility Criteria
You may qualify if:
- All patients referred for infertility receiving their first IVF or IVF+ICSI treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dronninglund Fertility Clinic
Dronninglund, 9330, Denmark
Fertility Clinic, Hvidovre Hospital
Hvidovre, 2650, Denmark
Related Publications (3)
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.
PMID: 29175067DERIVEDToftager 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.
PMID: 28130435DERIVEDToftager 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.
PMID: 27060174DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Thue Bryndorf
Hvidovre University Hospital
- STUDY CHAIR
Helle Meinertz
Hvidovre University Hospital
- PRINCIPAL INVESTIGATOR
Peter Hornnes
Hvidovre University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, DMSc
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 19, 2008
Study Start
January 1, 2009
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
January 13, 2016
Record last verified: 2016-01