Short Versus Long Protocol for IVF and IVF+ICSI
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 100-200 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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Infertility
Intervention
Patients receiving short protocol IVF/ICSI-treatment., Long protocol
Location
Dronninglund Fertility Clinic
Dronninglund
Denmark
9330
Status
Recruiting
Source
Hvidovre University Hospital
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00756028
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Withholding Treatment
Withholding or withdrawal of a particular treatment or treatments, often (but not necessarily) life-prolonging treatment, from a patient or from a research subject as part of a research protocol. The concept is differentiated from REFUSAL TO TREAT, where the emphasis is on the health professional's or health facility's refusal to treat a patient or group of patients when the patient or the patient's representative requests treatment. Withholding of life-prolonging treatment is usually indexed only with EUTHANASIA, PASSIVE, unless the distinction between withholding and withdrawing treatment, or the issue of withholding palliative rather than curative treatment, is discussed.
Procarbazine
An antineoplastic agent used primarily in combination with mechlorethamine, vincristine, and prednisone (the MOPP protocol) in the treatment of Hodgkin's disease.
Placebos
Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.
Gamete Intrafallopian Transfer
A technique that came into use in the mid-1980's for assisted conception in infertile women with normal fallopian tubes. The protocol consists of hormonal stimulation of the ovaries, followed by laparoscopic follicular aspiration of oocytes, and then the transfer of sperm and oocytes by catheterization into the fallopian tubes.
Medication Therapy Management
Assistance in managing and monitoring drug therapy for patients receiving treatment for cancer or chronic conditions such as asthma and diabetes, consulting with patients and their families on the proper use of medication; conducting wellness and disease prevention programs to improve public health; overseeing medication use in a variety of settings.
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