Differential Granulosa Cell Transcriptome Profiling as a Predictive Tool of Ongoing Pregnancy (GRANULOMIC)
Fertility problems are increasingly common in industrialized countries. It is estimated that 15-20% of couples of reproductive age have problems conceiving children naturally and the use of assisted reproductive treatment accounts for 1-3% of annual births. Among the causes of infertility, the female factor is responsible for approximately 40% of cases. The growing problem of infertility and the decline in the birth rate in Spain make absolutely necessary the improvement of assisted reproductive technology (ART). Actually, one of the main problems of ART is the election of the oocyte, as there is no method to select the best embryos for subsequent transfer. The average number of oocytes obtained from one woman in each cycle is 10-11, so the finding of a (some) biomarker(s) would have a great impact at a social and economic level and would commensurately reduce the economic cost of each cycle. Novel embryo assessment strategies are currently being developed and can be used alone or in combination with morphologic criteria. These include non-invasive methodologies as artificial intelligence using morphokinetic databases and the OMICS, like transcriptomic, proteomic and metabolomic. Among others, the transcriptome of the cumulus cells is a potentially valuable non-invasive biomarker. Indeed, it is already known that granulosa cells play a crucial role in the regulation of female fertility. The bi-directional communication between the oocyte and the surrounding cumulus cells is essential for the maturation of a developmentally competent oocyte, ovulation and fertilization, processes which are necessary for initiating and sustaining embryo development. Our work hypothesis is that the cumulus cell transcriptome would be directly related and give an essential information about oocyte maturation and fertilization ability.
Unfortunately, even though several studies on granulosa cell transcriptome analysis have been performed, the obtained data are still inconclusive. The main reason for this should be found in the study design which, in most cases, are performed in a small number of patients and presented a heterogeneous population.
Among others, there are great variations in the patients' age and physical characteristics, type of treatment, diagnosis, hormonal levels and endometrial receptivity. The main objective of this project is to find new unknown biomarker(s) of ongoing pregnancy by analyzing the whole transcriptome of the two granulosa cell layers surrounding the oocytes (cumulus cells and corona radiata). Specifically, the study aims to find a biomarker of oocyte maturity, of fertilization, of embryo quality, of euploid embryos, of pregnancy, early miscarriage or ongoing pregnancy, and finally, to find a correlation between these biomarkers and the morphokinetic of the embryos. An additional advantage of our project is the use of material that is obtained at the time of transvaginal ultrasound-guided oocyte retrieval but that is considered a waste and is usually discarded in Assisted Reproduction Centers. Therefore, the analysis of these cells does not suppose any change or bother for the women, in relation to the treatments of assisted reproduction.
調査の概要
状態
状態
条件
条件
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究場所
-
-
Sevilla
-
Seville、Sevilla、スペイン、41092
- 募集
- Vida Recoletas Sevilla
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コンタクト:
- Clara Palacio de Marco, MSc
- 電話番号:56661 0034954286274
- メール:vida.investiga@gruporecoletas.com
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コンタクト:
- Esther Santamaría López, MSc
- 電話番号:56739 0034954286274
- メール:vida.investiga@gruporecoletas.com
-
-
参加基準
適格基準
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
サンプリング方法
調査対象母集団
Women from 18 to 50 years of age attending VIDA Sevilla clinic for oocyte donation or reproductive treatment
説明
INCLUSION CRITERIA:
-
Advanced maternal age patients:
- Between 40 and 45 years old, both inclusive
- Patient at VIDA Sevilla
- IVF cycle with own oocytes (fresh)
- PGT-A cycle
- Consent to perform embryo culture in Embryoscope
-
Oocyte donors:
- Between 18 and 35 years old
- Being an oocyte donor accepted by VIDA Sevilla according to standard donor selection criteria at this clinic
-
Oocyte recipients:
- Patient at VIDA Sevilla
- Younger than 51 years old
- IVF cycle with fresh donor oocytes
- Consent to perform embryo culture in Embryoscope
- Matched donor already included in the study
EXCLUSION CRITERIA:
- Abnormal karyotype
- Reproductive tract anomalies
- Radio and chemotherapy treatments
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
- 観測モデル:OTHER
- 時間の展望:PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
|---|
|
AMA
Female IVF patients aged 40 or older, undergoing ICSI + PGT-A treatment with own oocytes |
|
FOD
Fresh oocyte donation cycle patients (donor and recipient) |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Identify predicitve biomarkers for ongoing pregnancy
時間枠:From enrollment to the end of follow-up at 8 weeks of gestational age.
|
Ongoing pregnancy is defined by the detection of a fetal heartbeat in a pregnancy. |
From enrollment to the end of follow-up at 8 weeks of gestational age.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- 2209-SEV-126-MF
- 25/1188 (その他の助成金/資金番号:Corporación Tecnológica de Andalucía)
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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