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

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ClinicalTrials.gov Identifier: NCT00756028
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):

Study Description
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).

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 or disease Intervention/treatment Phase
Infertility Ovarian Hyperstimulation Syndrome Quality of Life Live Birth Drug: Patients receiving short protocol IVF/ICSI-treatment. Drug: Long protocol Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1099 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study
Study Start Date : January 2009
Primary Completion Date : December 2014
Study Completion Date : December 2015
Arms and Interventions

Arm Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :
  1. Frequency of Ovarian Hyperstimulation Syndrome (OHSS) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Quality of life during treatment [ Time Frame: 3 years ]
  2. Live births [ Time Frame: 3 years ]
  3. Gene expression profiles of granulosa and cumulus cells [ Time Frame: 3 years ]
  4. Estradiol and vascular endothelial growth factor concentrations in follicular fluid. [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Hornnes, MD, DMSc, MD, DMSc, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00756028     History of Changes
Other Study ID Numbers: KvL
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Peter Hornnes, MD, DMSc, Hvidovre University Hospital:
quality of life

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action