Use of r-hLH (Luveris) in Donors Previously Treated With r-hFSH (Gonal F)
Use of r-hLH (Luveris) Late Follicular Phase for Controlled Ovarian Stimulation (COS) in Donor Patients Previously Treated With r-hFSH (Gonal F)in a Long Luteal Downregulated Cycle With GnRH Agonist. A Cross-over Study
調査の概要
状態
介入・治療
詳細な説明
While the role of FSH is considered the fundamental driver of folliculogenesis, the role of LH in this process is more controversial. FSH is associated with stimulating growth and recruitment of follicles while LH is associated with the selection of dominant follicles destined for ovulation. We will use an open, prospective, cross-over study to compare the safety and efficacy of two different treatment protocols for controlled ovarian stimulation in egg donors.
20 participants will undergo two cycles of stimulation. The first one will be with r-hFSH though the cycle and the second with r-hFSH then r-hLH. The participants will have 1 month rest cycle between the treatment cycles. r-hFSH doses will be adjusted according to patient response. r-hLH dosing will begin when there are 2 follicles greater than or equal to 14mm in diameter. The does will be 300IU/day and continue until the day of r-hCG administration.
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
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New Jersey
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Morristown、New Jersey、アメリカ、07960
- Reproductive Medicine Assoicates of New Jersey
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age less than or equal to 32 years old
- BMI<35
- Eligible for controlled ovarian simulation
- No PCO-type ovaries (PCO by USS image, >2.1 LH;FSH ratio on cycle day 3, insulin resistance, increase of testosterone over free testosterone)
- Meet all requirements for becoming an egg donor
- Willingness and ability to participate and comply with study protocol for the duration of the study
- Baseline FSH<11
Exclusion Criteria:
- Clinically significant systemic disease
- Any contraindication to gonadotropin therapy
- LH:FSH ratio greater than 3
- Pregnancy in the past 3 months
- Any medical condition which, in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug
- Simultaneous participation in another clinical trial
- Known active substance abuse, including tobacco and alcohol (>10 cigarettes/day)
- Refusal or inability to comply with protocol
- Known poor ovarian response
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：処理
- 割り当て：非ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
|---|---|
|
他の：r-hFSH (Gonal F)
Patients will be treated with r-hFSH throughout the stimulation phase of their first cycle until r-hCG administration.
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r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response
他の名前：
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他の：r-hFSH (Gonal F) and r-hLH (Luveris)
Patients will be treated with r-hFSH only until they have 2 follicles greater than or equal to 14mm.
Patients will then bring 300IU/day of r-hLH until r-hCG administration.
|
Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.
他の名前：
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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 |
|---|---|---|
|
Safety and efficacy of r-hFSH protocol
時間枠：6 months
|
Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
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6 months
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Safety and efficacy of r-hFSH + r-hLH protocol
時間枠：6 months
|
Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients.
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of oocytes retrieved
時間枠：6 months
|
Evaluation of the number of oocytes obtained as a function of stimulation protocol.
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6 months
|
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Quality of embryos obtained
時間枠：6 months
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Evaluation of pregnancy rates (clinical and ongoing), delivery rates, multiple pregnancy rates and the number of cancelled cycles.
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6 months
|
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Incidences of ovarian hyperstimulation syndrome
時間枠：6 months
|
Evaluation of the potential adverse effects associated with ovarian stimulation
|
6 months
|
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Quality of oocytes obtained
時間枠：6 months
|
Evaluation of the quality of oocytes obtained as a function of stimulation protocol.
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6 months
|
協力者と研究者
捜査官
- 主任研究者：Richard T Scott, MD、Reproductive Medicine Associates of new Jersey
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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