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Completed

NCT Number: NCT07568886

Albumin and Furosemide for Preventing Ovarian Hyperstimulation Syndrome in ICSI Patients

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.

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Key information

Conditions

Ovarian Hyper Stimulation Syndrome (OHSS)

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

High Institute for Infertility Diagnosis and ART

Baghdad, Baghdad Governorate, 10006, Iraq

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albumin (Human) 20%

Drug

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

Furosemide

Drug

Intravenous furosemide 20 mg administered after oocyte retrieval.

Standard luteal phase support

Drug

Routine luteal phase support according to institutional protocol.

Primary outcomes

  1. Incidence of Ovarian Hyperstimulation Syndrome

    Time frame: 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.

  2. Incidence of Moderate and Severe Ovarian Hyperstimulation Syndrome

    Time frame: Within 14 Days Post Oocyte Retrieval

    Defined according to standard OHSS classification criteria

Secondary outcomes

  1. Incidence of mild OHSS

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Al-Nahrain University

Other

Registry information

Official study title

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

Acronym: ALFURO-OHSS

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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