A multicentre randomized controlled trial on the efficacy of laser assisted hatching in poor prognosis patients undergoing IVF or ICSI.
Completed
- Conditions
- Assisted reproductive technologiesIVF / ICSIGeassisteerde voorplantingIVF / ICSI
- Registration Number
- NL-OMON26138
- Lead Sponsor
- Isala klinieken Zwolle
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 588
Inclusion Criteria
Repeated implantation failure.
Exclusion Criteria
1. Couples with no indication for IVF/ICSI treatment or with contraindications for IVF/ICSI treatment such as cardiovascular-pulmonary disease, severe diabetes, bleeding disorders, immunodeficiency and morbid obesity (i.e. a BMI of over 35);
2. Not able or willing to provide informed consent;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The live birth rate per couple included following one IVF/ICSI treatment, including pregnancies from cryopreserved and thawed embryos transferred before the end of the inclusion period.
- Secondary Outcome Measures
Name Time Method 1. The pregnancy rate (as defined by a positive pregnancy test 14 days following embryo transfer) per treatment cycle started, per oocyte retrieval and per embryo transfer, including pregnancies from cryopreserved and thawed embryos transferred before the end of the inclusion period;<br /><br>2. The ongoing pregnancy rate (a vital pregnancy 10 weeks after embryo transfer) per treatment cycle started, per oocyte retrieval and per embryo transfer, including pregnancies from cryopreserved and thawed embryos transferred before the end of the inclusion period;<br /><br>3. The implantation rate per embryo transferred;<br /><br>4. The multiple pregnancy rate;<br /><br>5. The monozygotic twinning rate;<br /><br>6. The percentage of major and minor malformations in the children born as assessed at birth.