The Efficacy and Safety of Female PRP Co-incubation With Sperm During (IUI) Cycles
28. maj 2026 opdateret af: Chung Pui Wah Jacqueline, Chinese University of Hong Kong
The Efficacy and Safety of Female Autologous Platelet-Rich Plasma (PRP) Co-incubation With Sperm During the Intrauterine Insemination (IUI) Cycles: A Prospective, Randomized Controlled Trial
The investigators hypothesize that infertility patients undergoing IUI who receive female autologous platelet-rich plasma (PRP) co-incubation with husband's sperm would have higher clinical pregnancy rate.
Primary outcome:
To compare the incidence of clinical pregnancy outcome in those infertility patients undergoing IUI with female PRP co-incubation with husband's sperm group and non-PRP group.
Secondary outcomes:
- To evaluate the post-culture sperm parameters between the intervention group and control group
- To evaluate the IUI parameter between the intervention group and control group
- To evaluate the safeness between the female PRP co-incubation with husband's sperm in the IUI group and non-PRP group, including potential infection rate or other pregnancy outcomes such as miscarriage, multiple pregnancy, ectopic pregnancy and molar pregnancy
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
288
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Hong Kong, Kina
- The Chinese University of Hong Kong
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Kontakt:
- Chung PW Jacqueline
- Telefonnummer: 35051537
- E-mail: jacquelinechung@cuhk.edu.hk
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Patients who were eligible for IUI cycles in Assissted Reproduction Technolog unit, Prince of Wales Hospital
- Female patients aged >18 years old and < 42 years old
- BMI < 30 kg/m2
Exclusion Criteria:
- Concurrent administration of other agents such as prednisolone, intravenous immunoglobulin, or G-CSF
- Administration of anticoagulants or NSAIDs at least 7 days before PRP infuse
- Drug addiction
- Untreated urinary tract infection
- Underlying uncontrolled diabetes or hypertension, chromosomal or uterine abnormalities, genetic, hematologic, immunological, or endocrine disorders
- Chronic disease, systemic disease or cancers
- Blood diseases (sepsis, thrombocytopenia)
- Poor sperm samples (raw sample TMS <5 x 106)
- Smoking and drinking alcoholic beverages on the day of IUI
- Fever on the day of IUI
- Redduse or incomplete in obtaining informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Sham-komparator: non-PRP group (control group)
non-PRP group (control group): non-PRP in the conventional IUI
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non-PRP group (control group): non-PRP in the conventional IUI
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Eksperimentel: PRP group (intervention group)
PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI
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PRP group (intervention group): female PRP co-incubation with husband's sperm in the IUI
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical pregnancy
Tidsramme: 6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI
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To determine the rate of clinical pregnancy outcome in subjects undergoing IUI with PRP co-incubation with husband's sperm group than non-PRP group.
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6 weeks gestation and ultrasound scanning will be performed to confirm at least one gestational sac around 2 to 3 months after IUI
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sperm motility
Tidsramme: after 30 minutes of co-culture
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To evaluate the Sperm motility between the intervention group and control group
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after 30 minutes of co-culture
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beta hCG positivity
Tidsramme: up to 24 weeks of IUI
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To evaluate the rate of beta hCG positivity between the intervention group and control group
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up to 24 weeks of IUI
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Infection or other complications
Tidsramme: up to 24 weeks of IUI
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To evaluate the rate of potential infection in the intervention group and control group
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up to 24 weeks of IUI
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Miscarriage
Tidsramme: up to 24 weeks of IUI
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To determine to the rate miscarriage outcome in the intervention group and control group
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up to 24 weeks of IUI
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Multiple pregnancy
Tidsramme: up to 24 weeks of IUI
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To determine to the rate of multiple pregnancy in the intervention group and control group
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up to 24 weeks of IUI
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Ectopic pregnancy
Tidsramme: up to 24 weeks of IUI
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To determine to the rate of ectopic pregnancy in the intervention group and control group
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up to 24 weeks of IUI
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Molar pregnancy
Tidsramme: up to 24 weeks of IUI
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To determine to the rate of molar pregnancy in the intervention group and control group
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up to 24 weeks of IUI
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
21. maj 2026
Primær færdiggørelse (Anslået)
20. november 2027
Studieafslutning (Anslået)
20. maj 2028
Datoer for studieregistrering
Først indsendt
6. maj 2026
Først indsendt, der opfyldte QC-kriterier
28. maj 2026
Først opslået (Faktiske)
29. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026.182
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