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.
- 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).N46N97.4Male infertilityFemale infertility associated with male factors
- Registration Number
- DRKS00010456
- Lead Sponsor
- IVF Zentren Prof. Zech
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 532
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.
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fertilization rate; blastocyst rate in both arms; pregnancy rate: number of positive hCG tests/ number of transfers approximately 2 weeks after embryo transfer.<br>Clinical pregnancy rate: verified heart beats /number of transfers approximately 8-12 weeks after embryo transfer.<br>Miscarriage rate: number of miscarriages after confirmed embryonal heart beat<br>Live Birth rate: number of live births.<br><br>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.<br>An assignment of the embryos to control and intervention arm is given by Software and CRF.<br>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.
- Secondary Outcome Measures
Name Time Method Elucidation of a putative Impact of artificial oocyte activation (by GM508) on the post- or neonatal outcome by questionnaire survey after delivery