PRP Improves Blastocyst Formation in ICSI Cycles (PRP ICSI SOAT)
5 maj 2026 uppdaterad av: 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
66
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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North Sumatra
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Medan, North Sumatra, Indonesien, 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
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: PRP
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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.
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Inget ingripande: Non-PRP
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Blastocyst formation rate (%)
Tidsram: From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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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.
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From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Fertilisation rate (%)
Tidsram: 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.
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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.
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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.
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Cleavage rate (%)
Tidsram: From enrollment to cleavage development (day 3). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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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.
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From enrollment to cleavage development (day 3). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Good-quality blastocyst (%)
Tidsram: From enrollment to blastocyst development (days 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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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.
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From enrollment to blastocyst development (days 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Fair-quality blastocyst (%)
Tidsram: 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.
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From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Poor-quality blastocyst (%)
Tidsram: From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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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.
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From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase.
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Samarbetspartners och utredare
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Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2023
Primärt slutförande (Faktisk)
30 augusti 2023
Avslutad studie (Faktisk)
30 december 2023
Studieregistreringsdatum
Först inskickad
5 maj 2026
Först inskickad som uppfyllde QC-kriterierna
5 maj 2026
Första postat (Faktisk)
12 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 maj 2026
Senast verifierad
1 januari 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 608.1/Dir/RSIA.SM/XII/2022
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