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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Peter Hornnes, MD, DMSc, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00756028
First received: September 18, 2008
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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
Infertility
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

Resource links provided by NLM:


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 ]

Estimated Enrollment: 1100
Study Start Date: January 2009
Estimated Study Completion Date: May 2015
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756028

Locations
Denmark
Dronninglund Fertility Clinic
Dronninglund, Denmark, 9330
Fertility Clinic, Hvidovre Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Peter Hornnes, MD, DMSc
Investigators
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
ClinicalTrials.gov Identifier: NCT00756028     History of Changes
Other Study ID Numbers: KvL
Study First Received: September 18, 2008
Last Updated: August 19, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
OHSS
quality of life
IVF
ICSI
GnRH-agonist
GnRH-antagonist

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

ClinicalTrials.gov processed this record on August 20, 2014