Embryo Development Using Two Commercial Single-step Media

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: embryo culture in different single-step media

• Registration Number: NCT02302638
• Lead Sponsor: Eugonia

Brief Summary

This prospective study with sibling oocytes will evaluate the efficiency of two commercial single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates. Embryos will be cultured continuously for up to 6 days under identical conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-11-27
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

• at least 10 oocytes retrieved

Exclusion Criteria

• frozen oocytes
• testicular biopsy
• less than 10 oocytes retrieved
• older than 40 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sage 1-step	embryo culture in different single-step media	Embryo culture in different single-step media: Half of each patient's oocytes will be randomly allocated to be cultured in Sage 1-step medium for up to six days following oocyte retrieval.
CSCM	embryo culture in different single-step media	Embryo culture in different single-step media: Half of each patient's oocytes will be randomly allocated to be cultured in CSC medium for up to six days following oocyte retrieval.

Primary Outcome Measures

Name	Time	Method
Utilization rates	6 days post oocyte retrieval	Utilization = embryos selected for transfer and cryopreservation
Blastocyst formation	5 days post oocyte retrieval	Number of blastocysts on day 5 post oocyte retrieval per fertilized oocytes

Secondary Outcome Measures

Name	Time	Method
Embryo quality on day 3	3 days post oocyte retrieval
blastocyst quality on day 5	5 days post oocyte retrieval
positive pregnancy test	15 days post oocyte retrieval
clinical pregnancy	7 weeks of gestation	presence of gestational sac with positive fetal heartbeat

Trial Locations

Locations (1)

Eugonia Assisted Reproduction Unit; 🇬🇷 Athens, Attica, Greece