Albumin and Furosemide for Preventing Ovarian Hyperstimulation Syndrome in ICSI Patients

NCT07568886 | Completed DMC

• 1 other identifier: AlNahrainU
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Hyper Stimulation Syndrome (OHSS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of mild OHSS

  14 days from ova pick up

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Participants receive standard luteal phase support only.

Drug: Standard luteal phase support

Albumin + Furosemide

EXPERIMENTAL

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: Albumin (Human) 20%; Drug: Furosemide; Drug: Standard luteal phase support

Interventions

Furosemide DRUG

Intravenous furosemide 20 mg administered after oocyte retrieval.

Albumin + Furosemide

Standard luteal phase support DRUG

Routine luteal phase support according to institutional protocol.

Albumin + Furosemide; Control Arm

Albumin (Human) 20% DRUG

Intravenous human albumin 20% (100 mL) administered immediately after oocyte retrieval.

Albumin + Furosemide

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: Female participants undergoing intracytoplasmic sperm injection (ICSI) cycles
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Any female who does not meet those criteria were excluded

Sponsors & Collaborators

• Al-Nahrain University: lead

Study Sites (1)

High Institute for Infertility Diagnosis and ART

Baghdad, Baghdad Governorate, 10006, Iraq

Location

MeSH Terms

Interventions

Albumins; Furosemide

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Wasan A Wasan Adnan Abduhameed, PhD

  high institute for infertility diagnosis and ART

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned into 2 parallel groups. Each group received a different intervention and were followed independently throughout the study period. The study compared the effect of albumin and furosemide administration versus standard care on the incidence and severity of ovarian hyperstimulation syndrome in women undergoing intracytoplasmic sperm injection (ICSI).

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 6, 2026
• Study Start: April 29, 2019
• Primary Completion: April 27, 2023
• Study Completion: April 1, 2024
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)