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PRP Improves Blastocyst Formation in ICSI Cycles (PRP ICSI SOAT)

5 maggio 2026 aggiornato da: Binarwan Halim, Stella Maris Women and Children Hospital

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

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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

66

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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 informed consent to participate in the study

Exclusion Criteria:

  1. leukospermia;
  2. a history of HIV, 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: PRP
Biologico: Platelet Rich Plasma
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.
Nessun intervento: Non-PRP

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Blastocyst formation rate (%)
Lasso di tempo: 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.
From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fertilisation rate (%)
Lasso di tempo: 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.
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 (%)
Lasso di tempo: 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.
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 (%)
Lasso di tempo: 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.
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 (%)
Lasso di tempo: 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.
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 (%)
Lasso di tempo: 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.
From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Stella Maris Women and Children Hospital

Collaboratori

Halim Fertility Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2023

Completamento primario (Effettivo)

30 agosto 2023

Completamento dello studio (Effettivo)

30 dicembre 2023

Date di iscrizione allo studio

Primo inviato

5 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 gennaio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 608.1/Dir/RSIA.SM/XII/2022

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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