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Clinical efficiency of a ready-to-use medium for human embryo culture supplemented with growth factors in patients with previous in vitro fertilization failures

Clinical efficiency of a ready-to-use medium for human embryo culture supplemented with granulocyte macrophage-colony stimulation factor GM-CSF (Embryogen ™) in patients with previous unsuccessful In vitro fertilization IVF-ICSI attempts, a prospective randomised study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94726536
Enrollment
500
Registered
2016-01-26
Start date
2012-01-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Intracytoplasmic sperm injection (ICSI) and embryo culture Pregnancy and Childbirth Intracytoplasmic sperm injection (ICSI) and embryo culture

Interventions

Participants are randomly allocated to one of two groups. Group 1: Participants receive intracytoplasmic sperm injection (ICSI) treatments carried out using ISM1 for embryo culture and transfer. Gro

Sponsors

Gynepro S.R.L.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female patients with at least one previous unsuccessful IVF attempt, in which a clinical pregnancy was not established (including biochemical pregnancies or miscarriages) 2. Aged between 25 and 45

Exclusion criteria

Exclusion criteria: 1. Women older than 45 years old 2. Patients with male partners with testicular spermatozoa or severe oligoastenoteratozoospermia (total sperm number less than 1,000,000 and sperm motility less than 5%)

Design outcomes

Primary

MeasureTime frame
Implantation rate (defined as the number of implanted embryos per number of transferred embryos) is measured 30 days after embryo transfer.

Secondary

MeasureTime frame
Pregnancy rate (defined as the number of pregnancies per number of transferred embryos) is measured using ultrasound of gestational chamber 30 days after embryo transfer.

Countries

Italy

Outcome results

None listed

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