Ovarian Hyper Stimulation Syndrome (OHSS)ALFURO-OHSSNCT07568886
Albumin and Furosemide for Preventing Ovarian Hyperstimulation Syndrome in ICSI Patients
A study testing Albumin (Human) 20%, Furosemide and Standard luteal phase support in people with Ovarian Hyper Stimulation Syndrome (OHSS), run by Al-Nahrain University at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Ovarian Hyper Stimulation Syndrome (OHSS)
- What is being tested?
- Albumin (Human) 20%, Furosemide and Standard luteal phase support
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIraq
- Study dates
- 29 Apr 2019to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Any female who does not meet those criteria were excluded
Trial locations and contacts
1 site in 1 country.
Iraq1 site
High Institute for Infertility Diagnosis and ART
Baghdad, Baghdad Governorate, 10006
About this study
Official 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
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.
Read more
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.
Read the 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
- Being tested
- Albumin (Human) 20%, Furosemide, Standard luteal phase support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Participants receive standard luteal phase support only. Receives: 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. Receives: Drug: Albumin (Human) 20%; Drug: Furosemide; Drug: Standard luteal phase support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ovarian Hyperstimulation Syndrome
Number of participants who develop ovarian hyperstimulation syndrome after ICSI in each study group.
Measured: 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
Measured: Within 14 Days Post Oocyte Retrieval
Secondary outcomes (1)
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
Measured: 14 days from ova pick up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start29 Apr 2019
- Primary completion27 Apr 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyper Stimulation Syndrome (OHSS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Nahrain University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mufeda Ali Jwad, Al-Nahrain University
- Investigators
- Wasan A Wasan Adnan Abduhameed, PhD, Study director, high institute for infertility diagnosis and ART
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568886
- Sponsor's protocol ID
- AlNahrainU
- Acronym
- ALFURO-OHSS
- Status last verified
- May 2026
- First submitted
- 20 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07568886
- Acronym / sponsor ID
- ALFURO-OHSS / AlNahrainU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Al-Nahrain UniversityUniversity, hospital or other
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Drug: Standard luteal phase supportParticipants receive standard luteal phase support only. |
| Albumin + Furosemide | Experimental | Drug: Albumin (Human) 20%, Drug: Furosemide, Drug: Standard luteal phase supportParticipants receive intravenous human albumin (20%, 100 mL) immediately after oocyte retrieval, followed by intravenous furosemide (20 mg), in addition to standard luteal phase support. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any female who does not meet those criteria were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin (Human) 20%Intravenous human albumin 20% (100 mL) administered immediately after oocyte retrieval. | Drug | Albumin + Furosemide |
| FurosemideIntravenous furosemide 20 mg administered after oocyte retrieval. | Drug | Albumin + Furosemide |
| Standard luteal phase supportRoutine luteal phase support according to institutional protocol. | Drug | Albumin + Furosemide, Control Arm |
Primary outcome
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.
Incidence of Moderate and Severe Ovarian Hyperstimulation Syndrome
Time frame: Within 14 Days Post Oocyte Retrieval
Defined according to standard OHSS classification criteria
1 secondary outcome
Incidence of mild OHSS
Time frame: 14 days from ova pick up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Ovarian Hyper Stimulation Syndrome (OHSS)
Recruiting
Ovarian Hyperstimulation Syndrome Prevention
Ovarian Hyper Stimulation Syndrome (OHSS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wasan A Wasan Adnan Abduhameed, PhD study director
high institute for infertility diagnosis and ART
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin (Human) 20%, Furosemide and Standard luteal phase support in people with Ovarian Hyper Stimulation Syndrome (OHSS), run by Al-Nahrain University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Ovarian Hyperstimulation Syndrome (time frame: From oocyte retrieval until 14 days after embryo transfer= 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.