Oocyte vitrification in women at risk of ovarian failure; an observational study with follow-up of childre

Withdrawn

Conditions: birth defect
congenital malformations
10027664

Registration Number: NL-OMON35039

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 190

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is the number of congenital abnormalities in babies born after<br /><br>oocyte vitrification (%). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the number of oocytes retrieved and vitrified per woman<br /><br>started (%), The number of women returning for thawing of oocytes (%), the live<br /><br>birth rate in women undergoing oocyte vitrification (%), the live birth rate<br /><br>per thaw cycle (%), the number of oocytes surviving the freeze-thaw process<br /><br>(%), the fertilisation rate (%), embryo development, number and type of<br /><br>pregnancy outcome (biochemical-, clinical-, ongoing-, multiple pregnancy rate<br /><br>(%) after freeze-thaw process.<br /><br>Furthermore the live birth rate after natural conception in the same risk group<br /><br>(%), women never becoming pregnant (%), the number of congenital abnormalities<br /><br>after spontaneous attempts (%), the number and type of pregnancy outcome<br /><br>(biochemical-, clinical-, ongoing-, multiple pregnancy rate after spontaneous<br /><br>attempts (%).<br /><br><br /><br><br /><br><br /><br><br /><br><br /><br></p><br>