A Comparative Study of Sibling Oocytes: ICSI vs. the PICSI 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 using a standard ICSI petri dish.

Group Type ACTIVE_COMPARATOR

ICSI petri dish

Intervention Type DEVICE

Half of the oocytes will be placed into the standard ICSI petri dish and they will be injected with sperm with normal morphology.

PICSI Procedure

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.

Group Type ACTIVE_COMPARATOR

PICSI petri dish

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No