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Completed

NCT Number: NCT07579858

PRP Improves Blastocyst Formation in ICSI Cycles

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

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Key information

Conditions

Severe Oligoasthenoteratozoospermia Blastocyst Blastocyst IVF Blastocyst Quality Blastocysts Embryo Development Embryo Quality Embryologic Parameters Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Oligospermia Platelet Rich Plasma Platelet Rich Plasma (PRP) Sperm Parameters in Fertile and Infertile Men Sperm Quality Spermatazoa Disorders Urogenital Diseases

Age range

28 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Blastocyst formation rate (%)

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

    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.

Secondary outcomes

  1. Fertilisation rate (%)

    Time frame: 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.

    Fertilisation rate refers to the percentage of mature eggs that are successfully fertilised after being combined with sperm in the laboratory. It is calculated by dividing the number of eggs that show normal signs of fertilisation by the total number of mature eggs used for insemination, then multiplying by 100. Normal fertilisation is identified by the presence of two distinct structures inside the egg when examined under a microscope approximately 16-18 hours after insemination.

  2. Cleavage rate (%)

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

    Cleavage rate refers to the percentage of fertilised eggs that undergo early cell division during the first 3 days of embryo development. It is calculated by dividing the number of fertilised eggs that successfully divide into two or more cells by the total number of normally fertilised eggs, then multiplying by 100. Embryos are observed under a microscope to confirm cell division and early development.

  3. Good-quality blastocyst (%)

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

    Good quality blastocyst refers to the proportion of embryos that develop into blastocysts by Day 5 and meet predefined criteria for high quality based on their appearance under a microscope. It is calculated by dividing the number of blastocysts classified as good quality by the total number of blastocysts formed, then multiplying by 100. Blastocyst quality is assessed using standard grading systems that evaluate the degree of expansion, the appearance of the inner cell mass and the outer cell layer. Only blastocysts meeting the predefined criteria for good quality are included.

  4. Fair-quality blastocyst (%)

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

    Fair quality blastocyst refers to the proportion of embryos that develop into blastocysts by Day 5 and meet predefined criteria for intermediate (fair) quality based on their appearance under a microscope. It is calculated by dividing the number of blastocysts classified as fair quality by the total number of blastocysts formed, then multiplying by 100. Blastocyst quality is assessed using standard grading systems that evaluate how expanded the blastocyst is, the appearance of its inner cell mass and outer cell layer. Only blastocysts meeting the predefined criteria for fair quality are included.

  5. Poor-quality blastocyst (%)

    Time frame: 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 refers to the proportion of embryos that develop into blastocysts by Day 5 but are classified as low quality based on their appearance under a microscope. It is calculated by dividing the number of blastocysts assessed as poor quality by the total number of blastocysts formed, then multiplying by 100. Blastocyst quality is evaluated using standard grading criteria that consider the degree of expansion, the appearance of the inner cell mass and the outer cell layer. Blastocysts that show limited expansion or irregular or poorly defined structures are classified as poor quality.

Sponsors and collaborators

Lead sponsor

Stella Maris Women and Children Hospital

Other

Collaborators

  • Halim Fertility Center

Registry information

Official study title

Efficacy of Platelet-rich Plasma on Blastocyst Formation in ICSI Cycles Involving Low-quality Sperm: A Randomised Study

Acronym: PRP ICSI SOAT

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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