Albumin and Furosemide for Preventing Ovarian Hyperstimul... | NCT07568886

Studies
Albumin and Furosemide for Preventing Ovarian Hyperstimulation Syndrome in ICSI Patients

NCT07568886

Sponsor

Al-Nahrain University

Status

Completed

Last Update Posted

May 6, 2026Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Ovarian Hyper Stimulation Syndrome (OHSS)

Interventions

Albumin (Human) 20%
Furosemide
Standard luteal phase support

Countries

Iraq

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 29, 2019Actual

Primary Completion Date

Apr 27, 2023Actual

Completion Date

Apr 1, 2024Actual

First Submitted Date

Apr 20, 2026

First Submission Date that Met QC Criteria

May 1, 2026

First Posted Date

May 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2026

Last Update Posted Date

May 6, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mufeda Ali Jwad, Principal Investigator, Al-Nahrain UniversityPrincipal Investigator

Lead Sponsor

Al-Nahrain UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Albumin (Human) 20%	Drug	Intravenous human albumin 20% (100 mL) administered immediately after oocyte retrieval.	Albumin + Furosemide

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female participants undergoing intracytoplasmic sperm injection (ICSI) cycles

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wasan A Wasan Adnan Abduhameed, PhD	high institute for infertility diagnosis and ART	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
High Institute for Infertility Diagnosis and ART		Baghdad	Baghdad Governorate	10006	Iraq

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_ICF	Yes	No	Yes	Study Protocol and Informed Consent Form	May 1, 2026	May 1, 2026	Prot_ICF_000.pdf

Intervention Browse Module

MeSH Terms

ID	Term
D000418	Albumins
D005665	Furosemide

Ancestor Terms

ID	Term
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D013424	Sulfanilamides
D013449	Sulfonamides

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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).