To determine safety and efficacy of oocyte vitrification.
ID
Source
Brief title
Condition
- Congenital and hereditary disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the number of congenital abnormalities in babies born after
oocyte vitrification (%).
Secondary outcome
Secondary outcomes are the number of oocytes retrieved and vitrified per woman
started (%), The number of women returning for thawing of oocytes (%), the live
birth rate in women undergoing oocyte vitrification (%), the live birth rate
per thaw cycle (%), the number of oocytes surviving the freeze-thaw process
(%), the fertilisation rate (%), embryo development, number and type of
pregnancy outcome (biochemical-, clinical-, ongoing-, multiple pregnancy rate
(%) after freeze-thaw process.
Furthermore the live birth rate after natural conception in the same risk group
(%), women never becoming pregnant (%), the number of congenital abnormalities
after spontaneous attempts (%), the number and type of pregnancy outcome
(biochemical-, clinical-, ongoing-, multiple pregnancy rate after spontaneous
attempts (%).
Background summary
Women of reproductive age at risk of ovarian failure, defined as loss of
ovarian function might benefit from oocyte vitrification to increase chances of
future motherhood. Oocyte vitrification, or ultra rapid egg freezing is a
relatively new technology with promising initial results. Worldwide over 900
babies have been born after egg freezing, of which 392 after oocyte
vitrification. In these babies, no apparent increase in congenital anomalies
was found. We aim to establish safety and efficacy of oocyte vitrification by
performing a large observational cohort study with follow up of women and
children.
Study objective
To determine safety and efficacy of oocyte vitrification.
Study design
Observational cohort study
Study burden and risks
After a standard IVF/ICSI cycle, i.e. a 3-week period with controlled ovarian
hormonal stimulation, ultrasound monitoring (4-5 times), endocrine monitoring
(4-5 times) and transvaginal follicle aspiration, oocytes are retrieved and
mature metaphase II (MF II) oocytes are vitrified using the Cryotop method.
They are stored for future use, when,- upon the request of the woman concerned-
these oocytes will be thawed, fertilized with intracytoplasmic sperm injection
(ICSI) and transferred to the uterus, with the intent of creating a successful
pregnancy. The risks to the women are limited to the risks associated with the
IVF/ICSI procedure such us ovarian hyperstimulation syndrome and infection, and
the risk of hitherto unknown complications of oocyte vitrification.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Oocyte vitrification will be offered to women at risk of ovarian failure due to iatrogenic gonadotoxic treatment or due to increasing age, as well as to women undergoing IVF/ICSI in whom unexpectedly no spermatozoa can be obtained at the time of follicle aspiration.;Inclusion criteria;1. Women between the age of 16 and 40 years who are at risk of ovarian failure due to iatrogenic gonadotoxic treatment (cancer treatment);2. Women between the age of 30 and 40 years who are at risk of ovarian failure due to increasing age. ;3. Women between the age of 18 and 42 years undergoing IVF/ICSI during which no
spermatozoa can be obtained at the time of follicle aspiration.
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 are, at the time of the requested thawing of their oocytes, above the age at which embryo transfer is considered safe: currently 45 years of age (modelreglement embryowet 2003)
5. Not able or willing to provide informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30772.000.10 |