birth defect congenital malformations
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Women until their 40th birthday who are at risk of ovarian failure due to iatrogenic gonadotoxic treatment. 2. Women until their 40th birthday who are at risk of premature ovarian failure and women between the ages of 30th and 40th birthday who are at risk of ovarian failure due to increasing age. 3. Women until their 43rd birthday undergoing an IVF/ICSI cycle during which no spermatozoa can be obtained at the time of follicle aspiration.
Exclusion criteria
Exclusion criteria: 1. Women with borderline or invasive ovarian cancer. 2. Women with contraindications for IVF treatment such as cardiovascular-pulmonary disease, severe diabetes, bleeding disorders, immunodeficiency, morbid obesity, and premature ovarian failure. 3. Women with severe psychopathology, severe anxiety and inability to cope. 4. Women who reach, at the time they request thawing of their oocyte, the maximum age at which embryo transfer is accepted by Dutch guidelines (currently from their 45th birthday). 5. Not able or willing to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is the number of congenital abnormalities in babies born after oocyte vitrification (%). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the number of oocytes retrieved and vitrified per woman started, the number of women requesting the use of their vitrified oocytes (%), the number of oocytes surviving the freeze-thaw process (%), the fertilisation rate (%), the percentage of top quality embryos (%), number and type of pregnancy outcome (biochemical-, clinical-, ongoing-, and multiple pregnancy rate (%)) after transfer of freeze-thawed and fertilized oocytes, the live birth rate in women undergoing oocyte vitrification (%), the live birth rate per thaw cycle (%). Also, the number of women desiring children (%), live birth rate after natural conception in the group under study (%), women intending to become pregnant but failed (%), the number of congenital abnormalities after natural conception (%), and the number and type of pregnancy outcome (biochemical-, clinical-, ongoing-, multiple pregnancy rate (%) after natural conception will be investigated. | — |
Countries
Netherlands
Outcome results
None listed