Is Rescue ICSI a useful tool in the routine IVF lab for patients undergoing total IVF fertilization failure?*

Is Rescue ICSI a useful tool in the routine IVF lab for patients undergoing total IVF fertilization failure?* - R-ICSI

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57127

Enrollment

Registered

2024-11-22

Start date

2026-02-04

Completion date

Unknown

Last updated

2026-03-09

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

Conditions

fertilization failure unfertilized oocyte

Interventions

We will compare the ongoing pregnancies between the pre intervention group (no R-ICSI) versus the post intervention group (R-ICSI).

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, the subjects must meet all the following criteria: • Couple is eligible for IVF (normal semen parameters) • Couple has read the Patient Information Folder (PIF) and signed the Informed Consent. • Woman is 40 years of age or less at the time of treatment. • Couple has at least 4 metaphase II (MII) oocytes with no visible 2nd polar body (PB) after the first fertilization check.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • All couples that have at least one confirmed normally fertilised oocyte (2PN) and are eligible for a fresh embryo transfer. • All couples that have less than four oocytes.

Design outcomes

Primary

Measure	Time frame
The primary parameters/endpoints of this study are: 1. Ongoing pregnancy rate from fresh embryo transfers (ET) in patients that have been undergoing the R-ICSI procedure and 2. Ongoing pregnancy rate following transfers with frozen embryos (FET) in patients that have supernumerary embryos frozen from the same R-ICSI cycle and 3. Cumulative ongoing pregnancy (cOPR) rates in patients that have both fresh and frozen embryos as a result of the same R-ICSI cycle.	—

Measure

Time frame

The primary parameters/endpoints of this study are: 1. Ongoing pregnancy rate from fresh embryo transfers (ET) in patients that have been undergoing the R-ICSI procedure and 2. Ongoing pregnancy rate following transfers with frozen embryos (FET) in patients that have supernumerary embryos frozen from the same R-ICSI cycle and 3. Cumulative ongoing pregnancy (cOPR) rates in patients that have both fresh and frozen embryos as a result of the same R-ICSI cycle.

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Secondary

Measure	Time frame
The following secondary endpoints of the study will be analysed: 4. fertilization rate after R-ICSI, 5. embryo usage rate (EUR) of embryos used for ET and cryopreservation after R-ICSI, 6. Pregnancy rate, 7. Implantation rate (IR) after transfer of fresh and/ or cryopreserved embryos after R-ICSI. 8. Further, a cost assessment will be incorporated in the results to assess whether R-ICSI implementation is financially more effective in place of an abandoned IVF cycle.	—

Measure

Time frame

The following secondary endpoints of the study will be analysed: 4. fertilization rate after R-ICSI, 5. embryo usage rate (EUR) of embryos used for ET and cryopreservation after R-ICSI, 6. Pregnancy rate, 7. Implantation rate (IR) after transfer of fresh and/ or cryopreserved embryos after R-ICSI. 8. Further, a cost assessment will be incorporated in the results to assess whether R-ICSI implementation is financially more effective in place of an abandoned IVF cycle.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026