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Reproductive Outcome After Sperm Selection for Intracytoplasmic Sperm Injection (ICSI) Using Zona Pellucida Proteins

Primary Purpose

Infertility, Male

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
Zona pellucida sperm selection
Conventional sperm selection
Intracytoplasmic Sperm Injection (ICSI)
Sponsored by
Nadezhda Women's Health Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male focused on measuring zona pellucida, sperm selection, ICSI, ART outcomes

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis for primary or secondary infertility
  • Healthy females
  • Clinical diagnosis for unexplained infertility
  • Females between 20 and 45 years old.
  • Males between 20 and 50 years old.
  • At least 3 retrieved oocytes per follicular puncture with at least 1 oocyte at germinal vesicle (GV) or metaphase I (MI) stage

Exclusion Criteria:

  • Presence of low quality oocytes
  • Females with endometrial or ovarian infertility factor

Sites / Locations

  • Nadezhda Women's Health Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zona pellucida sperm selection

Conventional sperm selection

Arm Description

Semen processing: liquefaction followed by centrifugation and swim-up. Zona pellucida sperm selection: Spermatozoa are selected according to their ability to adhere to zona pellucida proteins obtained from their partners native zona pellucida. Intracytoplasmic sperm injection (ICSI): Each oocyte is injected with a single morphologically normal spermatozoa. The injection procedure is carried out in a sterilized dish using holding pipette and injection needle.

Semen processing: liquefaction followed by centrifugation and swim-up. Samples are incubated until time of injection. Conventional sperm selection: Spermatozoa are selected according to their morphology. Intracytoplasmic sperm injection (ICSI): Each oocyte is injected with a single morphologically normal spermatozoa. The injection procedure is carried out in a sterilized dish using holding pipette and injection needle.

Outcomes

Primary Outcome Measures

Fertilisation rate
Defined as number of fertilized oocytes (presence of 2 pronuclei) per total number of injected oocytes.
Embryo quality
Morphological evaluation of the cultured embryos will be conducted 120 or 144 hr following sperm injection. Blastocysts scoring will be performed on day 5 or 6 depending on the blastocoel cavity expansion and on the inner cell mass and trophectoderm cells integrity.
Implantation rate
Defined as high levels of human chorionic gonadotropin (hCG) in the peripheral blood per transfer.
Clinical pregnancy rate
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 per number of embryo transferred.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2021
Last Updated
September 28, 2022
Sponsor
Nadezhda Women's Health Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05161247
Brief Title
Reproductive Outcome After Sperm Selection for Intracytoplasmic Sperm Injection (ICSI) Using Zona Pellucida Proteins
Official Title
Assessment of the IVF Outcome Parameters After Sperm Selection by Adhesion to Zona Pellucida Proteins
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
January 3, 2023 (Anticipated)
Study Completion Date
December 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nadezhda Women's Health Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to analyze the effect of a sperm selection method by adhesion to partners' zona pellucida proteins on the assisted reproduction treatment (ART) outcome parameters.
Detailed Description
The success rate after treatment by in-vitro fertilisation (IVF) depends on the sperm selection process. Classical sperm selection techniques are based on the spermatozoa morphology and motility, therefore are not able to measure the sperm ability to recognise the oocyte. Furthermore it is known that semen samples showing higher adherence rate to zona pellucida have higher fertilisation potential than spermatozoa that fail to bind to zona proteins. There have been numerous reports on applying partner' native zona pellucida in sperm selection prior ICSI. However, these studies imply the whole native zona pellucida, while this study will focus on the application of acid-solubilized zonae pellucidae. Here in this study, the aim is to assess the fertilisation rate, the number and quality of the formed embryos, implantation and ongoing pregnancy success after sperm selection for ICSI by their ability to adhere to immobilized zona pellucida proteins.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
Keywords
zona pellucida, sperm selection, ICSI, ART outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After couples are recruited for the study they will be randomly allocated to zona selection group (study group) and normal ICSI (control group). For the study group zonae pellucidae from germinal vesicle (GV) or metaphase I (MI) stage oocytes from the female partners will be collected and acid-solubilised to obtain zona proteins. The acid-solubilised zonae will be coated on petri dishes. On the day of their follicular punction the spermatozoa for ICSI in the study group will be selected according to their ability to adhere to the coated zona pellucida proteins from their partner. On the day of their follicular punction the spermatozoa for ICSI in the control group will be selected with no intervention.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zona pellucida sperm selection
Arm Type
Experimental
Arm Description
Semen processing: liquefaction followed by centrifugation and swim-up. Zona pellucida sperm selection: Spermatozoa are selected according to their ability to adhere to zona pellucida proteins obtained from their partners native zona pellucida. Intracytoplasmic sperm injection (ICSI): Each oocyte is injected with a single morphologically normal spermatozoa. The injection procedure is carried out in a sterilized dish using holding pipette and injection needle.
Arm Title
Conventional sperm selection
Arm Type
Active Comparator
Arm Description
Semen processing: liquefaction followed by centrifugation and swim-up. Samples are incubated until time of injection. Conventional sperm selection: Spermatozoa are selected according to their morphology. Intracytoplasmic sperm injection (ICSI): Each oocyte is injected with a single morphologically normal spermatozoa. The injection procedure is carried out in a sterilized dish using holding pipette and injection needle.
Intervention Type
Other
Intervention Name(s)
Zona pellucida sperm selection
Intervention Description
Sperm selection for ICSI based on the spermatozoa ability to adhere to immobilized zona pellucida proteins.
Intervention Type
Other
Intervention Name(s)
Conventional sperm selection
Intervention Description
Sperm selection for ICSI based on the sperm morphology.
Intervention Type
Other
Intervention Name(s)
Intracytoplasmic Sperm Injection (ICSI)
Intervention Description
Normal ICSI procedure.
Primary Outcome Measure Information:
Title
Fertilisation rate
Description
Defined as number of fertilized oocytes (presence of 2 pronuclei) per total number of injected oocytes.
Time Frame
24 hours after ICSI
Title
Embryo quality
Description
Morphological evaluation of the cultured embryos will be conducted 120 or 144 hr following sperm injection. Blastocysts scoring will be performed on day 5 or 6 depending on the blastocoel cavity expansion and on the inner cell mass and trophectoderm cells integrity.
Time Frame
2 to 6 days after ICSI
Title
Implantation rate
Description
Defined as high levels of human chorionic gonadotropin (hCG) in the peripheral blood per transfer.
Time Frame
14 days after embryo transfer
Title
Clinical pregnancy rate
Description
Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 per number of embryo transferred.
Time Frame
6 weeks after embryo transfer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis for primary or secondary infertility Healthy females Clinical diagnosis for unexplained infertility Females between 20 and 45 years old. Males between 20 and 50 years old. At least 3 retrieved oocytes per follicular puncture with at least 1 oocyte at germinal vesicle (GV) or metaphase I (MI) stage Exclusion Criteria: Presence of low quality oocytes Females with endometrial or ovarian infertility factor
Facility Information:
Facility Name
Nadezhda Women's Health Hospital
City
Sofia
ZIP/Postal Code
1373
Country
Bulgaria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reproductive Outcome After Sperm Selection for Intracytoplasmic Sperm Injection (ICSI) Using Zona Pellucida Proteins

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