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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICSI Procedure

The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte

Group Type ACTIVE_COMPARATOR

Standard ICSI procedure for sperm injection into oocyte

Intervention Type OTHER

The ICSI procedure is the standard procedure of selection and injection of sperm into oocytes

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)

Group Type ACTIVE_COMPARATOR

MSOME

Intervention Type DEVICE

Selection of ultramorphologically normal spermatozoa using an inverted microscope with 6300x magnification

IMSI Procedure

Intervention Type OTHER

Injection of sperm that has been selected by the MSOME method into oocytes

Interventions

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Standard ICSI procedure for sperm injection into oocyte

The ICSI procedure is the standard procedure of selection and injection of sperm into oocytes

Intervention Type OTHER

MSOME

Selection of ultramorphologically normal spermatozoa using an inverted microscope with 6300x magnification

Intervention Type DEVICE

IMSI Procedure

Injection of sperm that has been selected by the MSOME method into oocytes

Intervention Type OTHER

Other Intervention Names

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Motile Sperm Organelle Morphology Examination

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No