Albumin and Furosemide for Preventing Ovarian Hyperstimulation Syndrome in ICSI Patients (ALFURO-OHSS)
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.
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.
調査の概要
詳細な説明
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
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Baghdad Governorate
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Baghdad、Baghdad Governorate、イラク、10006
- High Institute for Infertility Diagnosis and ART
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Control Arm
Participants receive standard luteal phase support only.
|
Routine luteal phase support according to institutional protocol.
|
|
実験的：Albumin + Furosemide
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.
|
Routine luteal phase support according to institutional protocol.
Intravenous human albumin 20% (100 mL) administered immediately after oocyte retrieval.
Intravenous furosemide 20 mg administered after oocyte retrieval.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Ovarian Hyperstimulation Syndrome
時間枠：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.
|
From oocyte retrieval until 14 days after embryo transfer= 14 days
|
|
Incidence of Moderate and Severe Ovarian Hyperstimulation Syndrome
時間枠：Within 14 Days Post Oocyte Retrieval
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Defined according to standard OHSS classification criteria
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Within 14 Days Post Oocyte Retrieval
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of mild OHSS
時間枠：14 days from ova pick up
|
|
14 days from ova pick up
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Wasan A Wasan Adnan Abduhameed, PhD、High Institute for Infertility Diagnosis and ART
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AlNahrainU
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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