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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26138

Enrollment

588

Registered

2012-04-06

Start date

2012-11-28

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assisted reproductive technologies IVF / ICSI Geassisteerde voorplanting IVF / ICSI

Interventions

In the intervention group, the embryos to be transferred will undergo laser assisted hatching. One eighth of the ZP will be completely breached using the laser. Laser pulse duration should not exceed

Eligibility

Inclusion criteria

Inclusion criteria: Repeated implantation failure.

Exclusion criteria

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; 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). (conform: Standpunt inzake screening op infectieziekten bij kunstmatig geassisteerde voortplanting, www.embryologen.nl).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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; 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; 3. The implantation rate per embryo transferred; 4. The multiple pregnancy rate; 5. The monozygotic twinning rate; 6. The percentage of major and minor malformations in the children born as assessed at birth.	—

Measure

Time frame

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; 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; 3. The implantation rate per embryo transferred; 4. The multiple pregnancy rate; 5. The monozygotic twinning rate; 6. The percentage of major and minor malformations in the children born as assessed at birth.

—

Contacts

Public ContactM.H.J.M. Curfs

Fertility Centre Isala Isala klinieken P.O.Bos 10400

m.h.j.m.curfs@isala.nl+31 (0)38 4245888

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)