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

Not Applicable

• Conditions: Infertility
• Interventions: Device: ICSI petri dish; Device: PICSI petri dish

• Registration Number: NCT03240302
• Lead Sponsor: Hillel Yaffe Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-31
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-02
• Last Update Submitted: 2017-08-02
• Study First Posted: 2017-08-07
• Last Update Posted: 2017-08-07
• Study Start: 2017-09
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICSI Procedure	ICSI petri dish	The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte using a standard ICSI petri dish.
PICSI Procedure	PICSI petri dish	The PICSI procedure is based on a selection of mature spermatozoa with CD44 receptors and their injection into the oocyte using the PICSI petri dish that has been coated with hyaluronic acid on its bottom.

Primary Outcome Measures

Name	Time	Method
Comparison of fertilization rate	Three years	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.
Comparison of embryo quality	Three years	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.

Secondary Outcome Measures

Name	Time	Method
Live birth rate	Three years	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.
Implantation rate	Three years	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.
Pregnancy rate	Three years	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.
Miscarriage rate	Three years	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.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel