Albumin and Furosemide for Preventing Ovarian Hyperstimulation Syndrome in ICSI Patients (ALFURO-OHSS)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Baghdad Governorate
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Baghdad, Baghdad Governorate, Irak, 10006
- High Institute for Infertility Diagnosis and ART
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Control Arm
Participants receive standard luteal phase support only.
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Routine luteal phase support according to institutional protocol.
|
|
Expérimental: 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.
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Routine luteal phase support according to institutional protocol.
Intravenous human albumin 20% (100 mL) administered immediately after oocyte retrieval.
Intravenous furosemide 20 mg administered after oocyte retrieval.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Ovarian Hyperstimulation Syndrome
Délai: 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
Délai: Within 14 Days Post Oocyte Retrieval
|
Defined according to standard OHSS classification criteria
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Within 14 Days Post Oocyte Retrieval
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of mild OHSS
Délai: 14 days from ova pick up
|
|
14 days from ova pick up
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Wasan A Wasan Adnan Abduhameed, PhD, High Institute for Infertility Diagnosis and ART
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AlNahrainU
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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