Skip to main content
OpenTrials
Completed

NCT Number: NCT00756028

Short Versus Long Protocol for IVF and IVF+ICSI

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Live Birth Ovarian Diseases Ovarian Hyperstimulation Syndrome Quality of Life Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Dronninglund Fertility Clinic, Dronninglund, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients receiving short protocol IVF/ICSI-treatment.

Drug

Injection s.c. Orgalutran® (Ganirelix)0.25 mg once daily from day 5 of FSH-stimulation until HCG-day

Long protocol

Drug

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

Primary outcomes

  1. Frequency of Ovarian Hyperstimulation Syndrome (OHSS)

    Time frame: 3 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Peter Hornnes, MD, DMSc

Other

Registry information

Official study title

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

Acronym: KvL

Important dates

Study start
2009
Primary completion
2014
Study completion
2015
First posted
Sep 19, 2008
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.