Evaluation of the Impact of Vitrification on Oocytes
Evaluation of the Impact of Vitrification on the Reproductive Performance and Potential of Human Oocytes
調査の概要
詳細な説明
This study will recruit patients from the NY/NJ/CT/eastern PA area only.
Cryopreservation of human oocytes has a great potential to preserve or extend fertility in the face of disease whose treatment would result in a loss of ovarian function. (malignancy, severe autoimmune disease, etc.). It would also provide a means of quarantining oocytes to be used in oocyte donation to provide the lowest possible risk of infection.
There are two methods for storage of oocytes: slow freezing or vitrification. Slow freezing is the conventional method and has been successfully used for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. However, the technique has not been rigorously validated to date. The aim of this study is to determine the rate of cryosurvival of mature oocytes following vitrification, and to then compare the reproductive potential of vitrified oocytes relative to those which have not been cryopreserved.
Patients will undergo ovarian stimulation for in vitro fertilization (IVF) according to the protocol recommended by their primary doctor. After retrieval, mature oocytes will be divided in half. One half will undergo vitrification, immediate thaw and intracytoplasmic sperm injection (ICSI). The other half will undergo just ICSI. All embryos will then develop on identical culture until day 3 or day 5. Prior to transfer, the best embryo from each group will undergo biopsy for genetic fingerprinting. The patient will have a 2 embryo transfer (one from each group). All extra embryos will be biopsied for pre-implantation genetic diagnosis (PGD) prior to being cryopreserved. If the patient becomes pregnant, we will follow up with an additional blood draw at approximately 9 weeks gestation and buccal swabs after the delivery of the infant(s).
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
-
-
New Jersey
-
Morristown、New Jersey、アメリカ、07960
- Reproductive Medicine Associates of new Jersey
-
-
Pennsylvania
-
Allentown、Pennsylvania、アメリカ、18104
- Reproductive Medicine Assoicates of PA at Lehigh Valley
-
-
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
This study will recruit patients from the NY/NJ/CT/eastern PA area only.
Inclusion Criteria:
- No prior failed IVF treatment cycle
- Female partner less than 35 years of age at time of onset of the IVF cycle
- Normal maximum prior day 3 follicle stimulating hormone (FSH) level (< or = 10 IU/L)
- Total basal antral follicle count greater than or equal to 12
- Male partner with greater than 100,000 total motile spermatozoa Donor sperm is acceptable but the couples will be required to provide one additional vial for DNA analysis
- Body Mass Index (BMI) ≤ 32 kg/m2
Exclusion Criteria:
- Diagnosis of chronic oligoovulation or anovulation (cycle typically occurring less often than every 38 days)
- Diagnosis of endometrial insufficiency
- Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)
- Use of testicular aspiration or biopsy procedures to obtain sperm
- Unevaluated ovarian mass
- Presence of hydrosalpinges which communicate with the endometrial cavity
- Any contraindication to undergoing in vitro fertilization or gonadotropin stimulation
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
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Oocyte Vitrification
Each patient will have oocytes randomized into two groups immediately after retrieval.
Half of oocytes will be vitrified, thawed and inseminated.
The other half will be inseminated only.
All embryos will be biopsied for PGD prior to transfer and one embryo from each group will be transferred (vitrification and control groups).
Following delivery, buccal swabs will be collected on all infants.
|
Half of the oocytes retrieved from each patient will undergo vitrification, immediate thaw and insemination.
All embryos will undergo biopsy for PGD prior to transfer.
他の名前：
|
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 |
|---|---|---|
|
Aneuploidy Rate (evaluation of whether embryo is chromosomally normal)
時間枠：1 year
|
Compare the rate of chromosomally-abnormal embryos among embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Delivery rates
時間枠：1 year
|
All embryos will be biopsied prior to transfer and DNA samples will be collected from all infants.
Compare embryonic and infant DNA to evaluate whether the live birth resulted from a vitrified or a fresh/control oocyte.
|
1 year
|
|
Paired Sustained Implantation Rate (number of viable fetuses beyond the first trimester per embryo transferred)
時間枠：1 year
|
Among patients with a paired two blastocyst transfer, compare the implantation rate of embryos originating from vitrified oocytes versus embryos originating from fresh/control oocytes.
|
1 year
|
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。