Clinical trial NCT05161247: 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
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Male
Keywords: zona pellucida
sperm selection
ICSI
ART outcomes
Lead sponsor: Nadezhda Women's Health Hospital
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 368
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fertilisation rate
timeFrame: 24 hours after ICSI
measure: Embryo quality
timeFrame: 2 to 6 days after ICSI
measure: Implantation rate
timeFrame: 14 days after embryo transfer
measure: Clinical pregnancy rate
timeFrame: 6 weeks after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Nadezhda Women's Health Hospital
Study officials:
References: