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A controlled randomized trial evaluating two different embryo culture systems following IVF/ ICSI: sequential medium in 5% oxygen atmosphere and monoculture medium in 21% oxygen atmosphere

A controlled randomized trial evaluating two different embryo culture systems following IVF/ ICSI: sequential medium in 5% oxygen atmosphere and monoculture medium in 21% oxygen atmosphere

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00000638
Enrollment
261
Registered
2010-12-16
Start date
2009-02-10
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

N97

Interventions

Group 1: In the control group, (n=114) oocytes were treated exclusively in media of Gynemed, Germany.) After retrieval they were rinsed in GM501 wash solution and then incubated in 600 ul of GM501C

Sponsors

Wunschbaby-Zentrum
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to 50 Years

Inclusion criteria

Inclusion criteria: A treatment cycle was enrolled in the study if at least one ovarian follicle > 16 mm was monitored at ultrasound 2 days before the retrieval. Only first-cycle patients undergoing routine IVF or ICSI were recruited for this study. Thus the number of cycles was equal to the number of patients enrolled.

Exclusion criteria

Exclusion criteria: Patients were excluded if no oocyte could be retrieved.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the biochemical pregnancy rate (hCG > 10 mu/ml serum) of the patients, estimated not earlier than day 15 after oocyte retrieval.

Secondary

MeasureTime frame
Secondary endpoints are: ICSI-fertilization rate, cleavage rate of fertilized oocytes, number of transferred embryos, implantation rate, live-birth implantation rate, clinical pregnancy rate, live birth rate and frequency of cryopreservation. ICSI-fertilization rate was calculated by the number of 2 PN embryos obtained by ICSI divided by the number of mature oocytes retrieved. The cleavage rate is the number of cleaved oocytes divided by the number of fertilized oocytes. The implantation rate is defined as the number of intruterine sacs observed by ultrasound within 8 weeks of embryo transfer divided by the number of embryos transferred. The live-birth implantation rate ist the number of babies born alive divided by the number of embryos transferred. The clinical pregnancy rate was calculated as the number of patients with at least one intrauterine sac observed by ultrsound within 8 weeks of embryo transfer divided by the number of patients with an oocyte retrieval. The live birth rate ist the number of patients with one or more live-born infants divided by the number of patients with an oocyte retrieved.

Countries

Austria

Contacts

Public ContactPeter Kemeter

Wunschbaby-Zentrum

peter.kemeter@aon.at+436649224886

Outcome results

None listed

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