Embryo Development Using Two Commercial Single-step Media

Infertility Clinical Trial

Official title:

Embryo Development and Utilization Using Two Commercial Single-step Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302638
• Other study ID #: Sage vs CSCM
• Status: Completed
• Phase: N/A
• First received: November 25, 2014
• Last updated: June 8, 2015
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Eugonia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and WelfareGreece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• at least 10 oocytes retrieved

Exclusion Criteria:

• frozen oocytes

• testicular biopsy

• less than 10 oocytes retrieved

• older than 40 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• embryo culture in different single-step media
Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.

Locations

Country	Name	City	State
Greece	Eugonia Assisted Reproduction Unit	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utilization rates	Utilization = embryos selected for transfer and cryopreservation	6 days post oocyte retrieval	No
Primary	Blastocyst formation	Number of blastocysts on day 5 post oocyte retrieval per fertilized oocytes	5 days post oocyte retrieval	No
Secondary	Embryo quality on day 3		3 days post oocyte retrieval	No
Secondary	blastocyst quality on day 5		5 days post oocyte retrieval	No
Secondary	positive pregnancy test		15 days post oocyte retrieval	No
Secondary	clinical pregnancy	presence of gestational sac with positive fetal heartbeat	7 weeks of gestation	No

External Links

•   Blastocyst development in single-step versus sequential culture media: a prospective randomized study with sibling oocytes