Short Versus Long Protocol for IVF and IVF+ICSI

Quality of Life Clinical Trial

— KvL  

Official title:

Short Versus Long IVF-treatment. A Prospective, Consecutive and Randomized Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756028
• Other study ID #: KvL
• Status: Completed
• Phase: Phase 4
• First received: September 18, 2008
• Last updated: January 12, 2016
• Start date: January 2009
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1099
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Live Birth
• Ovarian Hyperstimulation Syndrome
• Quality of Life

Intervention

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
• Long protocol
Patients receiving long protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-agonist (Synarela®:Nafarelin)

Locations

Country	Name	City	State
Denmark	Dronninglund Fertility Clinic	Dronninglund
Denmark	Fertility Clinic, Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Peter Hornnes, MD, DMSc

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Ovarian Hyperstimulation Syndrome (OHSS)		3 years	Yes
Secondary	Quality of life during treatment		3 years	No
Secondary	Live births		3 years	No
Secondary	Gene expression profiles of granulosa and cumulus cells		3 years	No
Secondary	Estradiol and vascular endothelial growth factor concentrations in follicular fluid.		3 years	No