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

Not Applicable

• Conditions: Infertility
• Interventions: Other: Standard ICSI procedure for sperm injection into oocyte; Device: MSOME; Other: IMSI Procedure

• Registration Number: NCT03240276
• 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 defined as Moderate OTA or Isolated Teratozoospermia with less than 4% morphologically normal spermatozoa
• Patients with 0.5- 7% normal sperm according to MSOME analysis
• Females with normal FSH and AMH values
• Females who have retrieved at least 6 oocytes in previous cycles
• Couples who have had at least 2 failed IVF-ICSI cycles

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	Standard ICSI procedure for sperm injection into oocyte	The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte
IMSI Procedure	MSOME	The IMSI procedure is the injection of normal ultramorphological spermatozoa that have been selected using an inverted microscope with magnification of 6300x (MSOME)
IMSI Procedure	IMSI Procedure	The IMSI procedure is the injection of normal ultramorphological spermatozoa that have been selected using an inverted microscope with magnification of 6300x (MSOME)

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 IMSI 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 IMSI methods will be compared.

Secondary Outcome Measures

Name	Time	Method
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 IMSI 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 IMSI 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 IMSI methods will be compared.
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 IMSI methods will be compared.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 H̱adera, Israel