Short Versus Long Protocol for IVF and IVF+ICSI (KvL)

This study has been completed.
Information provided by (Responsible Party):
Peter Hornnes, MD, DMSc, Hvidovre University Hospital Identifier:
First received: September 18, 2008
Last updated: January 12, 2016
Last verified: January 2016

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.

Condition Intervention Phase
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

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 ]

Enrollment: 1099
Study Start Date: January 2009
Study Completion Date: December 2015
Primary Completion Date: December 2014 (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.


Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00756028

Dronninglund Fertility Clinic
Dronninglund, Denmark, 9330
Fertility Clinic, Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Peter Hornnes, MD, DMSc
Study Chair: Thue Bryndorf Hvidovre University Hospital
Study Chair: Helle Meinertz Hvidovre University Hospital
Principal Investigator: Peter Hornnes Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Peter Hornnes, MD, DMSc, MD, DMSc, Hvidovre University Hospital Identifier: NCT00756028     History of Changes
Other Study ID Numbers: KvL 
Study First Received: September 18, 2008
Last Updated: January 12, 2016
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
quality of life

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases processed this record on February 07, 2016