Albumin and Furosemide for Preventing Ovarian Hyperstimulation Syndrome in ICSI Patients

Al-Nahrain University200 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

Interventions

Albumin (Human) 20%DRUG

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

FurosemideDRUG

Intravenous furosemide 20 mg administered after oocyte retrieval.

Standard luteal phase supportDRUG

Routine luteal phase support according to institutional protocol.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

High Institute for Infertility Diagnosis and ART

Baghdad, Baghdad Governorate, Iraq

Outcomes

Primary Outcomes

Incidence of Ovarian Hyperstimulation Syndrome

Number of participants who develop ovarian hyperstimulation syndrome after ICSI in each study group.

Time frame: 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

Time frame: Within 14 Days Post Oocyte Retrieval

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

Time frame: 14 days from ova pick up

Data from ClinicalTrials.gov

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