Short Versus Long Protocol for IVF and IVF+ICSI - Full Text View

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00756028

Purpose

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.

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

MedlinePlus related topics: Infertility

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	1100
Study Start Date:	November 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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 100-200 patients are used for developing a 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

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

Contacts

Contact: Thue Bryndorf	+4536326763	thue.bryndorf@gmail.com
Contact: Trine Holland	+4536323632

Locations

Denmark
Fertility Clinic, Hvidovre Hospital
Hvidovre, Denmark, 2650
Dronninglund Fertility Clinic
Dronninglund, Denmark, 9330

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

Principal Investigator:	Thue Bryndorf	Hvidovre Hospital
Study Chair:	Helle Meinertz	Hvidovre Hospital

More Information

No publications provided

Responsible Party:	Region Hovedstadens Sygehusvæsen ( Hvidovre Fertility Clinic, Department of Obstetrics and Gynecology, Hvidovre Hospital )
Study ID Numbers:	KvL
Study First Received:	September 18, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00756028 History of Changes
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

Study placed in the following topic categories:

Genital Diseases, Female
Deslorelin
Infertility
Nafarelin
Ganirelix
Gonadal Disorders

Ovarian Hyperstimulation Syndrome
Quality of Life
Endocrine System Diseases
Endocrinopathy
Ovarian Diseases
Genital Diseases, Male

Additional relevant MeSH terms:

Genital Diseases, Female
Infertility
Pathologic Processes
Disease
Gonadal Disorders
Ovarian Hyperstimulation Syndrome

Syndrome
Endocrine System Diseases
Ovarian Diseases
Genital Diseases, Male
Adnexal Diseases

ClinicalTrials.gov processed this record on May 07, 2009