Benefit of oocyte activation with GM508 CultActive in an IVF/ICSI therapy with different clinical pictures of sub- or infertility. A prospective – randomized pilot study.

Benefit of oocyte activation with GM508 CultActive in an IVF/ICSI therapy with different clinical pictures of sub- or infertility. A prospective – randomized pilot study. - GM508 CultActive in IVF/ICSI therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010456

Enrollment

512

Registered

2016-04-27

Start date

2016-04-15

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Patients with male sub- or infertility including oligoasthenoteratozoospermia of different grades as well as (non-)obstructive azoospermia. Couples with reduced fertilization rate of unclear aetiology in an ICSI cycle but potentially normal sperm parameters. Couples with reduced embryonal cleavage rate or reduced blastocyst rate in (an) previous ICSI cycle(s). N46 N97.4

Interventions

Group 1: Half of the retrieved oocytes were randomized to arm 1 and fertilized by ICSI, followed by artificial oocyte activation with GM508 CultActive (Gynemed) according to a standardized protocol. E

Eligibility

Sex/Gender

All

Age

18 Years to 43 Years

Inclusion criteria

Inclusion criteria: All IVF couples with indications for artificial oocyte activation that have signed an informed consent before therapy. Indications are: • Male sub- or infertility including oligoasthenoteratozoospermia of different grades and obstructive and non-obstructive azoospermia including cycles with fertilization after testicular sperm extraction (TESE) • Couples with reduced fertilization rate after ICSI, but potentially normal spermiocytogram, as well as patients with observed reduced embryonic cleavage rate or reduced blastocyst rate after ICSI.

Exclusion criteria

Exclusion criteria: Less than 2 mature (MII) oocytes after retrieval • female age =44 Years (no age restrictions for males ) • known chromosomal abberations of one or both partners • egg donnation patients • Patients with total globozoospermia (therefore oocyte activation is obligate)

Design outcomes

Primary

Measure	Time frame
Fertilization rate; blastocyst rate in both arms; pregnancy rate: number of positive hCG tests/ number of transfers approximately 2 weeks after embryo transfer. Clinical pregnancy rate: verified heart beats /number of transfers approximately 8-12 weeks after embryo transfer. Miscarriage rate: number of miscarriages after confirmed embryonal heart beat Live Birth rate: number of live births. Transfer is performed by using the morphological "best" embryo according to the stadardized criteria of Gardner et al., 2000. In case of equal embryo quality in both arms, the embryo selection is randomized. An assignment of the embryos to control and intervention arm is given by Software and CRF. In the case of DET, wherein both of embryos are taken from different arms , the resulting outcome parameters for pregnancy and birth are excluded from the study evaluation.	—

Measure

Time frame

Fertilization rate; blastocyst rate in both arms; pregnancy rate: number of positive hCG tests/ number of transfers approximately 2 weeks after embryo transfer. Clinical pregnancy rate: verified heart beats /number of transfers approximately 8-12 weeks after embryo transfer. Miscarriage rate: number of miscarriages after confirmed embryonal heart beat Live Birth rate: number of live births. Transfer is performed by using the morphological "best" embryo according to the stadardized criteria of Gardner et al., 2000. In case of equal embryo quality in both arms, the embryo selection is randomized. An assignment of the embryos to control and intervention arm is given by Software and CRF. In the case of DET, wherein both of embryos are taken from different arms , the resulting outcome parameters for pregnancy and birth are excluded from the study evaluation.

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Secondary

Measure	Time frame
Elucidation of a putative Impact of artificial oocyte activation (by GM508) on the post- or neonatal outcome by questionnaire survey after delivery	—

Countries

Austria

Contacts

Public ContactMaximilian Murtinger

IVF Zentren Prof. Zech

zech@ivf.at+43 5574 44836

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026