Ovarian Hyper Stimulation Syndrome (OHSS)
Conditions
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
Interventions
DRUGAlbumin (Human) 20%
Intravenous human albumin 20% (100 mL) administered immediately after oocyte retrieval.
DRUGFurosemide
Intravenous furosemide 20 mg administered after oocyte retrieval.
DRUGStandard luteal phase support
Routine luteal phase support according to institutional protocol.
Sponsors
Al-Nahrain University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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).
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Ovarian Hyperstimulation Syndrome | 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 | Within 14 Days Post Oocyte Retrieval | Defined according to standard OHSS classification criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of mild OHSS | 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 |
Countries
Iraq
Contacts
STUDY_DIRECTORWasan A Wasan Adnan Abduhameed, PhD
high institute for infertility diagnosis and ART
Outcome results
None listed