A Comparative Study of Sibling Oocytes: ICSI vs. the PICSI Sperm Selection Method

Infertility Clinical Trial

Official title:

A Comparative Study of Sibling Oocytes, Which Examines Two Sperm Selection Methods for Top Quality of Spermatozoa , Prior Intracytoplasmic Sperm Injection (ICSI) Performance, and Their Effect on Embryo Quality and IVF Outcome: A Common Selection Method Based on Morphology (ICSI) vs. a Selection Method for Mature Spermatozoa With CD44 Receptors for Hyaluronic Acid (PICSI - Physiological Selected Intracytoplasmic Sperm Injection)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03240302
• Other study ID #: HYMC-0069-17
• Status: Not yet recruiting
• Phase: N/A
• First received: July 31, 2017
• Last updated: August 2, 2017
• Start date: September 2017
• Est. completion date: September 2020

Study information

• Verified date: August 2017
• Source: Hillel Yaffe Medical Center
• Contact: Medeia Michaeli, PhD
• Phone: 972-50-6246885
• Email: medeia.michaeli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and IVF outcome.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Males aged 18-60

• Females aged 18-35

• Males with mild OTA (oligo terato astheno zoospermia) and at least one failed IVF cycle

• Males with normozoospermia with at least 2 unexplained failed IVF cycles

• Females with normal FSH and normal AMH values

• Females who have retrieved in previous cycles at least 6 oocytes

Exclusion Criteria:

• Couples who have been exposed to heavy smoking, drugs and chronic diseases

• Males who have undergone testicular surgery (TESE) or defined as severe OTA

• Females with egg factor infertility

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• ICSI petri dish
Half of the oocytes will be placed into the standard ICSI petri dish and they will be injected with sperm with normal morphology.
• PICSI petri dish
Half of the oocytes will be placed into a PICSI petri dish (whose bottom is coated with hyaluronic acid) and the mature spermatozoa with CD44 receptors that are attached to the bottom of the dish will be injected into them.

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of fertilization rate	Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The fertilization rates of the ICSI and PICSI methods will be compared.	Three years
Primary	Comparison of embryo quality	Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The embryo quality of the ICSI and PICSI methods will be compared.	Three years
Secondary	Implantation rate	Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The implantation rates of the ICSI and PICSI methods will be compared.	Three years
Secondary	Pregnancy rate	Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The pregnancy rates of the ICSI and PICSI methods will be compared.	Three years
Secondary	Miscarriage rate	Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The miscarriage rates of the ICSI and PICSI methods will be compared.	Three years
Secondary	Live birth rate	Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The live birth rates of the ICSI and PICSI methods will be compared.	Three years