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CompletedNCT07579858PRP ICSI SOATUpdated May 12, 2026

PRP Improves Blastocyst Formation in ICSI Cycles

A Phase 3 interventional study of Platelet Rich Plasma in Severe Oligoasthenoteratozoospermia, Sperm Quality and Spermatazoa Disorders, sponsored by Stella Maris Women and Children Hospital. Completed at 1 site in Indonesia. Open to male participants aged 28 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Stella Maris Women and Children Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Jan 2023, registered May 2026).
Phase
Phase 3
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
28 Years to 45 Years
Sex
Male
01

Study 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
02

Conditions studied

  • 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

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Keywords

  • Platelet-rich plasma
  • Severe oligoasthenoteratozoospermia
  • Blastocyst formation
  • Embryo development
  • Sperm quality
03

In context

Oligospermia

64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.

This study's enrollment of 66 is close to the median of 65 across 46 interventional studies indexed under Oligospermia.

Browse Oligospermia studies →

Lead sponsor

Stella Maris Women and Children Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. sperm concentration of less than five million/mL;
  2. total sperm motility \< 42%;
  3. sperm normal morphology of less than four percent;
  4. provided to participate in the study

Exclusion criteria

Exclusion Criteria:

  1. leukospermia;
  2. a history of , hepatitis, or other reproductive tract infections;
  3. a history of utilising drugs or therapies within the past three months, such as antibiotics, radiotherapy, chemotherapy, psychiatric medications, or anabolic steroids;
  4. a history of fever within the past three months;
  5. a history of testicular carcinoma;
  6. using a second ejaculate sample for ICSI;
  7. using a cryopreserved semen sample for ICSI;
  8. a history of retrograde ejaculation;
  9. a history of coagulopathy
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    PRP

    Biological: Platelet Rich Plasma

  • No intervention
    Non-PRP

Interventions

  • 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.

06

What researchers measure

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.

    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.

Secondary outcomes

  1. Fertilisation rate (%)

    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.

    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.

  2. Cleavage rate (%)

    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.

    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.

  3. Good-quality blastocyst (%)

    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.

    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.

  4. Fair-quality blastocyst (%)

    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.

    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.

  5. Poor-quality blastocyst (%)

    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.

    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.

07

Study locations

1 site
  • 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
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07579858
Lead sponsor
Stella Maris Women and Children Hospital
Collaborators
Halim Fertility Center
Responsible party
Binarwan Halim (Associate Professor, Stella Maris Women and Children Hospital) — Principal investigator
First posted
May 12, 2026
Start date
Jan 1, 2023
Primary completion
Aug 30, 2023
Completion
Dec 30, 2023
Last update
May 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Platelet rich plasma

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