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.

Study Overview

• Status: Completed
• Conditions: Ovarian Hyper Stimulation Syndrome (OHSS)
• Intervention / Treatment: Drug: Standard luteal phase support; Drug: Albumin (Human) 20%; Drug: Furosemide

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; Participants receive standard luteal phase support only.	Drug: Standard luteal phase support; Routine luteal phase support according to institutional protocol.
Experimental: 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.	Drug: Standard luteal phase support; Routine luteal phase support according to institutional protocol.; Drug: Albumin (Human) 20%; Intravenous human albumin 20% (100 mL) administered immediately after oocyte retrieval.; Drug: Furosemide; Intravenous furosemide 20 mg administered after oocyte retrieval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Ovarian Hyperstimulation Syndrome	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	Defined according to standard OHSS classification criteria	Within 14 Days Post Oocyte Retrieval

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	14 days from ova pick up

Collaborators and Investigators

• Sponsor: Al-Nahrain University
• Investigators: Study Director: Wasan A Wasan Adnan Abduhameed, PhD, High Institute for Infertility Diagnosis and ART

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Sulfur Compounds; Organic Chemicals; Amides; Aniline Compounds; Amines; Sulfonamides; Sulfanilamides; Sulfones; Furosemide; Albumins
• Other Study ID Numbers: AlNahrainU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No