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Embryo development of fresh versus vitrified metaphase II after intracytoplasmic sperm injection (ICSI): a sibling-oocyte study

Embryo development of fresh versus vitrified metaphase II after intracytoplasmic sperm injection (ICSI): a prospective randomised active-controlled parallel group sibling-oocyte study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN60158641
Enrollment
40
Registered
2009-05-29
Start date
2008-09-02
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Intracytoplasmic sperm injection cases, oocyte vitrification Pregnancy and Childbirth Fertilisation difficulties

Interventions

After oocyte denudation, MII oocytes with normal morphology were randomly allocated to fresh ICSI insemination or to vitrification procedure. If pregnancy was not obtained a subsequent ICSI cycle was

Sponsors

G.EN.E.R.A. - Clinica Valle Giulia (Italy)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Between September 2008 and February 2009 consecutive patients not older than 42 years of age, presenting greater than 6 normal appearing metaphase II (MII) oocytes and undergoing ICSI treatment with ejaculated sperm in the Centre for Reproductive Medicine GENERA in Rome.

Exclusion criteria

Exclusion criteria: 1. Female partner older than 42 years old 2. Less than 6 normal appearing MII oocytes retrieved 3. Surgically extracted spermatozoa 4. Very severe oligoastenoteratozoospermia (motile sperm count less than 500,000/ml after preparation) 5. Patients enrolled in our polar body biopsy programme

Design outcomes

Primary

MeasureTime frame
Non-inferiority in fertilisation rates calculated per warmed and per injected oocyte, assessed 16 - 18 hours post-treatment (ICSI).

Secondary

MeasureTime frame
1. Pronuclear morphology 2. Embryo development, assessed 42 - 44 hours post-treatment 3. Patient's baseline characteristics 4. Clinical outcomes

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026