Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer

Infertility Clinical Trial

Official title:

Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01773603
• Other study ID #: MC0405
• Secondary ID: IMH2013-1
• Status: Terminated
• Phase: N/A
• First received: January 18, 2013
• Last updated: January 18, 2013
• Start date: December 2011
• Est. completion date: July 2012

Study information

• Verified date: January 2013
• Source: Memorial Sisli Hospital, Istanbul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion.

This study was designed to select for the top blastocyst to be replaced, while increasing the pregnancy chance, with the local legislation regulating the number of embryos to be transferred and to establish a morphokinetic standard to be used in our clinical setting.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• patients in their first or second ART treatment cycle

• no recurrent spontaneous abortions

• age<35 years

• BMI<28 kg/m2

• =8 oocytes retrieved

Exclusion Criteria:

• severe endometriosis

• polycystic ovary syndrome

• hydrosalpynx

• uterine pathology

• severe male factor (presenting less than 5 million motile sperm cells in total in the ejaculate)

• very severe morphological sperm defects (mainly globozoospermic or macrocephalic samples)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• Embryoscope
Five-day embryo culture in embryoscope which is an incubator with a built-in camera

Locations

Country	Name	City	State
Turkey	Sisli Memorial Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Murat Çetinkaya

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastocyst formation rate		5th day of embryonic development	No
Secondary	Clinical pregnancy rate	Clinical pregnancy was defined as the presence of a gestational sac detected on ultrasound 3 weeks after the first ßhCG test, which was performed 14 days after oocyte retrieval.	7th week of pregnancy	No