The main objective is to determine if assisted hatching improves the live birth rate in poor prognosis patients. The secondary objective is to gather information on the safety of assisted hatching as determined by the number of congenital…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
onvervulde kinderwens
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is 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 (cumulative
live birth rate).
Secondary outcome
Secondary study parameters are:
- 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;
- 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;
- the implantation rate per embryo transferred;
- the multiple pregnancy rate;
- the monozygotic twinning rate;
- the percentage of major and minor malformations in the children born as
assessed at birth.
Background summary
Hatching is the process in which the embryo is extruded from the zona pellucida
which surrounds the oocyte and the embryo just before implantation in the
endometrium. Artificial reproductive technologies such as IVF and ICSI have
been brought in relation to alterations in the zona pellucida, thereby
hampering hatching and diminishing pregnancy rates.
Assisted hatching is a laboratory technique which might overcome this negative
influence by breaching, dissolving of weakening the zona pellucida. Assisted
hatching is applied in many centres worldwide, albeit not in The Netherlands.
There is scientific evidence that assisted hatching might especially be
effective in poor prognosis patients, however the evidence regarding the
efficacy of assisted hatching expressed as live birth rate is only weak.
The goal of this study is to provide evidence whether assisted hatching
positively influences the live birth rate in poor prognosis patients undergoing
IVF or ICSI.
Study objective
The main objective is to determine if assisted hatching improves the live birth
rate in poor prognosis patients. The secondary objective is to gather
information on the safety of assisted hatching as determined by the number of
congenital abnormalities diagnosed perinatally in comparison with the control
group.
Study design
Double blind multicentre randomized controlled intervention study.
Intervention
Patients will be randomized between no intervention and the intervention laser
assisted hatching on the embryos transferred. In the latter case in one focus
plane, one eighth of the the zona pellucida will be removed.
Study burden and risks
The burden in the patients allocated to assisted hatching is comparable to that
of control patients, i.e. both groups receive a standard IVF or ICSI treatment.
In addition, all patients with an ongoing pregnancy will receive a
questionnaire on the perinatal outcome of the pregnancy. Embryos in the
intervention group will undergo laser assisted hatching before transfer,
possibly leading to improved implantation rates. The benefit for the patients
in the intervention group is possibly an increased live birth rate. The major
risk for the embryos and patients is an increased monozygotic twinning rate
after assisted hatching.
Dr Spanjaarweg 29
Zwolle 8025 BT
NL
Dr Spanjaarweg 29
Zwolle 8025 BT
NL
Listed location countries
Age
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).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL36590.000.12 |