The effect of PVP 10% and PVP 5% on the embryo and sperm

Comparison between PVP5% and PVP 10% on the sperm DNA fragmentation, and HSP70, BAX, BCL2 genes expression, fertilization rate, embryo development and pregnancy outcomes in clinical ICSI cycles.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220725055550N1

Enrollment

Registered

2022-11-24

Start date

2022-12-20

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male infertility. Male infertility

Interventions

Intervention 1: Intervention group: Using PVP 5% to immobilize sperm in the ICSI procedure. Intervention 2: Control group: Using PVP 10% to immobilize sperm in the ICSI procedure.

Eligibility

Sex/Gender

All

Age

20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Men with male infertility factors who participate in the study

Exclusion criteria

Exclusion criteria: Obstructive (OA) or non-obstructive (NOA) azoospermia patients, over 40 years old, HIV positive patient

Design outcomes

Primary

Measure	Time frame
Fertilization rate. Timepoint: Sixteen to 20 hours after performing of assisted reproductive technique. Method of measurement: Appearance of pronucleus by binocular loop observation.	—

Secondary

Measure	Time frame
Rate of chemical pregnancy. Timepoint: Two weeks after performing of assisted reproductive technique. Method of measurement: Measurement of serum Beta-Human Chorionic Gonadotropin.;Rate of clinical pregnancy. Timepoint: Rate of clinical pregnancy is evaluated 6 weeks after assisted reproductive technique. Method of measurement: Clinical pregnancy is measured through the recording of heart beat by ultrasonography.;Embryo quality. Timepoint: The second or third day after performing the assisted reproductive technique. Method of measurement: Investigating the total number of normal blastomers and fragmented blastomeres percentage.;Time lapse parameters. Timepoint: After intracytoplasmic injection of sperm (time 0), the following time points are measured: Time of disappearance of pronucleus in zygote (tPNF), Zygote divides into two cells (T2), three cells (T3), four cells (T4), five cells (T5), six cells (T6), seven cells (T7) and eight cells (T8). Method of measurement: Analyzing and measurement using EmbryoViewerTM software.	—

Measure

Time frame

Rate of chemical pregnancy. Timepoint: Two weeks after performing of assisted reproductive technique. Method of measurement: Measurement of serum Beta-Human Chorionic Gonadotropin.;Rate of clinical pregnancy. Timepoint: Rate of clinical pregnancy is evaluated 6 weeks after assisted reproductive technique. Method of measurement: Clinical pregnancy is measured through the recording of heart beat by ultrasonography.;Embryo quality. Timepoint: The second or third day after performing the assisted reproductive technique. Method of measurement: Investigating the total number of normal blastomers and fragmented blastomeres percentage.;Time lapse parameters. Timepoint: After intracytoplasmic injection of sperm (time 0), the following time points are measured: Time of disappearance of pronucleus in zygote (tPNF), Zygote divides into two cells (T2), three cells (T3), four cells (T4), five cells (T5), six cells (T6), seven cells (T7) and eight cells (T8). Method of measurement: Analyzing and measurement using EmbryoViewerTM software.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Ali Khalili

Yazd University of Medical Sciences

khalili59@hotmail.com+98 35 3824 8119

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026