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Albumin and Furosemide for Preventing Ovarian Hyperstimulation Syndrome in ICSI Patients (ALFURO-OHSS)

1. maj 2026 opdateret af: Mufeda Ali Jwad, Al-Nahrain University

Effect of Albumin and Furosemide Combination for Prevention of Severe Ovarian Hyperstimulation Syndrome in Hyper-Responders Undergoing Intracytoplasmic Sperm Injection Cycles: A Randomized Controlled Trial

This study aims to evaluate whether the combination of Albumin and Furosemide can reduce the risk of Ovarian Hyperstimulation Syndrome in women undergoing intracytoplasmic sperm injection (ICSI) who are at high risk of developing this condition.

Ovarian hyperstimulation syndrome is a potential complication of ovarian stimulation during assisted reproductive techniques, which can lead to symptoms such as abdominal swelling, fluid accumulation, and, in severe cases, hospitalization. Preventing this condition is important to improve patient safety and treatment outcomes.

In this randomized controlled study, eligible women undergoing ICSI were assigned to receive either the combination of albumin and furosemide or standard care. The study compared the occurrence and severity of OHSS between the two groups.

The results of this study may help identify an effective strategy to prevent OHSS and improve the safety of assisted reproductive treatments.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized controlled clinical trial conducted in women undergoing intracytoplasmic sperm injection (ICSI) who are at high risk of developing ovarian hyperstimulation syndrome (OHSS). Participants were randomly allocated into study groups to receive either a combination protocol of albumin and furosemide or standard care.

The study was designed to evaluate the effectiveness of this intervention in reducing the incidence and severity of OHSS. Ovarian hyperstimulation syndrome is a potentially serious complication of controlled ovarian stimulation in assisted reproductive techniques and may result in abdominal distension, fluid accumulation, and hospitalization in severe cases.

The Primary Outcome:

• Incidence of moderate and severe OHSS within 14 days post oocyte retrieval

The Secondary Outcomes:

  • Incidence of mild OHSS
  • Ovarian volume changes
  • Serum estradiol levels on trigger day
  • Hematocrit levels post retrieval
  • Endometrial thickness and vascularity indices
  • Hospital admission rate
  • Clinical pregnancy rate

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Irak
    • Baghdad Governorate
      • Baghdad, Baghdad Governorate, Irak, 10006
        • High Institute for Infertility Diagnosis and ART

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:

- The inclusion criteria were females aged ≤35 years old, previous history of severe OHSS, AMH> 3.4, antral follicles count ≥22, presence of >18 follicles with a diameter >11 mm at any day of the stimulation cycle, serum estradiol ≥3500 pg/ml at day of hCG trigger, and aspiration of >15 oocytes at day of oocyte pick up.

Exclusion Criteria:

  • Any female who does not meet those criteria were excluded

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control Arm
Participants receive standard luteal phase support only.
Medicin: Standard luteal phase support
Routine luteal phase support according to institutional protocol.
Eksperimentel: Albumin + Furosemide
Participants receive intravenous human albumin (20%, 100 mL) immediately after oocyte retrieval, followed by intravenous furosemide (20 mg), in addition to standard luteal phase support.
Medicin: Standard luteal phase support
Routine luteal phase support according to institutional protocol.
Medicin: Albumin (Human) 20%
Intravenous human albumin 20% (100 mL) administered immediately after oocyte retrieval.
Medicin: Furosemide
Intravenous furosemide 20 mg administered after oocyte retrieval.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Ovarian Hyperstimulation Syndrome
Tidsramme: From oocyte retrieval until 14 days after embryo transfer= 14 days
Number of participants who develop ovarian hyperstimulation syndrome after ICSI in each study group.
From oocyte retrieval until 14 days after embryo transfer= 14 days
Incidence of Moderate and Severe Ovarian Hyperstimulation Syndrome
Tidsramme: Within 14 Days Post Oocyte Retrieval
Defined according to standard OHSS classification criteria
Within 14 Days Post Oocyte Retrieval

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of mild OHSS
Tidsramme: 14 days from ova pick up
  • Ovarian volume changes
  • Serum estradiol levels on trigger day
  • Hematocrit levels post retrieval
  • Endometrial thickness and vascularity indices
  • Hospital admission rate
  • Clinical pregnancy rate
14 days from ova pick up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Al-Nahrain University

Efterforskere

  • Studieleder: Wasan A Wasan Adnan Abduhameed, PhD, High Institute for Infertility Diagnosis and ART

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 (Faktiske)

29. april 2019

Primær færdiggørelse (Faktiske)

27. april 2023

Studieafslutning (Faktiske)

1. april 2024

Datoer for studieregistrering

Først indsendt

20. april 2026

Først indsendt, der opfyldte QC-kriterier

1. maj 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AlNahrainU

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be publicly shared due to patient privacy considerations and the sensitive nature of reproductive health information collected in this study. However, aggregate data will be reported in publications and may be made available upon reasonable request to the corresponding author, subject to institutional and ethical approval.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ovarialt hyperstimuleringssyndrom (OHSS)

Kliniske forsøg med Standard luteal phase support

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