PRP Improves Blastocyst Formation in ICSI Cycles

NCT07579858 | Completed Phase 3

• 1 other identifier: 608.1/Dir/RSIA.SM/XII/2022
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if platelet rich plasma (PRP) works to improve embryo development rates and embryo quality in IVF cycles, involving male adult patients with severe sperm disorders. The main questions it aims to answer are:

• Does PRP improve sperm quality of male adult patients undergoing IVF?
• Does PRP improve embryo development and embryo quality of the IVF patients? Researchers will compare embryos from IVF patients treated with PRP to those not treated with PRP to see if PRP improves embryo development and embryo quality. Participants will:
• Provide semen sample for IVF
• Provide blood sample for PRP preparation
• Have PRP obtained from their blood added to their sperm sample

Conditions

Severe Oligoasthenoteratozoospermia; Sperm Quality; Spermatazoa Disorders; Sperm Parameters in Fertile and Infertile Men; Embryo Development; Embryo Quality; Embryologic Parameters; Platelet Rich Plasma; Platelet Rich Plasma (PRP); Blastocyst Quality; Blastocyst IVF; Blastocyst; Blastocysts

Keywords

Platelet-rich plasma; Severe oligoasthenoteratozoospermia; Blastocyst formation; Embryo development; Sperm quality

Outcome Measures

Primary Outcomes (1)

• Blastocyst formation rate (%)

  Blastocyst formation rate is defined as the proportion of fertilised oocytes that successfully develop into blastocysts by Day 5 of embryo culture. It is calculated as the number of embryos reaching the blastocyst stage on Day 5 divided by the total number of normally fertilised oocytes (2 pronuclei, 2PN), expressed as a percentage. Embryo development is assessed using standard morphological criteria under microscopy, and only embryos meeting established blastocyst-stage characteristics are included in the numerator.

  From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.

Secondary Outcomes (5)

• Fertilisation rate (%)

  From enrollment to fertilisation of the embryo (day 1). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.

• Cleavage rate (%)

  From enrollment to cleavage development (day 3). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.

• Good-quality blastocyst (%)

  From enrollment to blastocyst development (days 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.

• Fair-quality blastocyst (%)

  From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.

• Poor-quality blastocyst (%)

  From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.

Study Arms (2)

PRP

EXPERIMENTAL

Biological: Platelet Rich Plasma

Non-PRP

NO INTERVENTION

Interventions

Platelet Rich Plasma BIOLOGICAL

Platelet-rich plasma (PRP) will be prepared from autologous blood collected from each participant. The blood sample will undergo centrifugation at 1400 rpm for 15 minutes to separate and concentrate the platelet-rich fraction. The resulting PRP will then be isolated and added to the participant's sperm sample for use in the IVF procedure.

PRP

Eligibility Criteria

• Age: 28 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• sperm concentration of less than five million/mL;
• total sperm motility \< 42%;
• sperm normal morphology of less than four percent;
• provided informed consent to participate in the study

You may not qualify if:

• leukospermia;
• a history of HIV, hepatitis, or other reproductive tract infections;
• a history of utilising drugs or therapies within the past three months, such as antibiotics, radiotherapy, chemotherapy, psychiatric medications, or anabolic steroids;
• a history of fever within the past three months;
• a history of testicular carcinoma;
• using a second ejaculate sample for ICSI;
• using a cryopreserved semen sample for ICSI;
• a history of retrograde ejaculation;
• a history of coagulopathy

Sponsors & Collaborators

• Stella Maris Women and Children Hospital: lead
• Halim Fertility Center: collaborator

Study Sites (1)

Halim Fertility Center, RSIA Stella Maris lantai 5, Jl. Samanhudi No.20, J A T I, Kec. Medan Maimun, Kota Medan, Sumatera Utara 20152

Medan, North Sumatra, 20152, Indonesia

Location

MeSH Terms

Conditions

Oligospermia

Condition Hierarchy (Ancestors)

Infertility, Male; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: January 1, 2023
• Primary Completion: August 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 12, 2026

Record last verified: 2026-01

Locations

ID (1)