PRP Improves Blastocyst Formation in ICSI Cycles (PRP ICSI SOAT)
5 mai 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Les conditions
- Développement d'embryons
- Blastocyste
- Plasma riche en plaquettes
- Qualité du sperme
- Qualité de l'embryon
- Plasma riche en plaquettes (PRP)
- Paramètres du sperme chez les hommes fertiles et infertiles
- Troubles des spermatozoïdes
- Blastocystes
- Paramètres Embryologiques
- Blastocyst IVF
- Qualité du blastocyste
- Severe Oligoasthenoteratozoospermia
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
66
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Sumatra
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Medan, North Sumatra, Indonésie, 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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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Aucune intervention: Non-PRP
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Blastocyst formation rate (%)
Délai: 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.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fertilisation rate (%)
Délai: 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 (%)
Délai: 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.
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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 (%)
Délai: 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.
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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 (%)
Délai: 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.
|
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Poor-quality blastocyst (%)
Délai: 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.
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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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2023
Achèvement primaire (Réel)
30 août 2023
Achèvement de l'étude (Réel)
30 décembre 2023
Dates d'inscription aux études
Première soumission
5 mai 2026
Première soumission répondant aux critères de contrôle qualité
5 mai 2026
Première publication (Réel)
12 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 mai 2026
Dernière vérification
1 janvier 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 608.1/Dir/RSIA.SM/XII/2022
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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