A multicentre randomized controlled trial on the efficacy of laser assisted hatching in poor prognosis patients undergoing IVF or ICSI

Completed

Conditions: onvervulde kinderwens
subfertility - assisted reproductive technologies

Registration Number: NL-OMON29700

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 588

Inclusion Criteria

Patients with an indication for an IVF/ICSI treatment which meet the following criterium:
- Repeated implantation failure.

Exclusion Criteria

1. No indication for IVF/ICSI treatment or with contraindications for IVF/ICSI treatment;
2. Not able or willing to provide informed consent;
3. Unable to speak or read the Dutch language;
4. Medical contraindication for pregnancy or childbirth;
5. Positive serology for Hepatitis B (in the case of ICSI) or HIV (in the case of IVF and ICSI).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the live birth rate per couple included<br /><br>following one IVF/ICSI treatment, including pregnancies from cryopreserved and<br /><br>thawed embryos transferred before the end of the inclusion period (cumulative<br /><br>live birth rate).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are:<br /><br>- the pregnancy rate (as defined by a positive pregnancy test 14 days following<br /><br>embryo transfer) per treatment cycle started, per oocyte retrieval and per<br /><br>embryo transfer, including pregnancies from cryopreserved and thawed embryos<br /><br>transferred before the end of the inclusion period;<br /><br>- the ongoing pregnancy rate (a vital pregnancy 10 weeks after embryo transfer)<br /><br>per treatment cycle started, per oocyte retrieval and per embryo transfer,<br /><br>including pregnancies from cryopreserved and thawed embryos transferred before<br /><br>the end of the inclusion period;<br /><br>- the implantation rate per embryo transferred;<br /><br>- the multiple pregnancy rate;<br /><br>- the monozygotic twinning rate;<br /><br>- the percentage of major and minor malformations in the children born as<br /><br>assessed at birth.</p><br>