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

Peter Hornnes, MD, DMSc

Status and phase: Completed; Phase 4

Conditions: Live Birth; Ovarian Hyperstimulation Syndrome; Infertility; Quality of Life

Treatments: Drug: Patients receiving short protocol IVF/ICSI-treatment.; Drug: Long protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT00756028

KvL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,099 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,099 participants in 2 patient groups

1

Experimental group

Description:

Patients receiving short protocol IVF/ICSI-treatment. Intervention pharmacon: GnRH-antagonist (Orgalutran®: Ganirelix)

Treatment:

Drug: Patients receiving short protocol IVF/ICSI-treatment.

2

Active Comparator group

Description:

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

Treatment:

Drug: Long protocol