SIRT3 Expression in Granulosa Cells and the Levels of Follicular Fluid Metabolites Among POR Subgroups
NCT ID: NCT06617988
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
80 participants
OBSERVATIONAL
2024-10-15
2025-02-15
Brief Summary
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1. Can the relative expression level of SIRT3 differentiate between POR subtypes, and do these differences reflect distinct metabolic characteristics among the subtypes?
2. Investigate whether SIRT3 expression levels correlate with clinical outcomes. This study will enroll patients with various POR subtypes and collect discarded follicular fluid and granulosa cells on the day of egg retrieval. IVF outcome information routinely collected in electronic databases will also be recorded. Notably, this is a purely observational study with no additional interventions. Your participation will not alter your clinical treatment compared to other patients.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Normal prognosis group (control group)
Participants included in this group should have normal ovarian reserve: number of antral follicle count ≥5, level of anti-Mullerian hormone ≥1.2 ng/ml, and number of oocytes retrieved in the present IVF-ET cycles\>9. All participants in this group receive the standard operation protocol for In vitro fertilization and embryo transfer.
Not applicable- observational study
Not applicable- observational study
Unexpected poor prognosis group
Participants included in this group should have normal ovarian reserve but a poor ovarian response, defined as: number of antral follicle count ≥5, level of anti-Müllerian hormone ≥1.2ng/ml, and number of oocytes retrieved in the present IVF-ET cycles ≤ 9. All participants in this group will receive the standard operation for in vitro fertilization and embryo transfer.
Not applicable- observational study
Not applicable- observational study
Poor prognosis of advanced maternal age group
Participants included in this group are characterized by advanced age (≥35 years) and meet at least one of the following criteria: 1. Number of oocytes retrieved in the current IVF cycle ≤9; 2. Diminished ovarian reserve: level of anti-Mullerian hormone\<1.2 ng/ml or number of antral follicle count \<5. All participants in this group receive the standard operation protocol for In vitro fertilization and embryo transfer.
Not applicable- observational study
Not applicable- observational study
Expected poor prognosis group
Participants included in this group should have diminished ovarian reserve: number of antral follicle count\<5 and level of anti-Mullerian hormone\<1.2 ng/ml. All participants in this group receive the standard operation protocol for In vitro fertilization and embryo transfer.
Not applicable- observational study
Not applicable- observational study
Interventions
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Not applicable- observational study
Not applicable- observational study
Eligibility Criteria
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Inclusion Criteria
* 2\. Individuals undergoing their first or second cycle of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), with a scheduled fresh embryo transfer;
* 3\. Participants must fulfill the diagnostic criteria corresponding to one of the following prognostic categories as determined by the clinician: Normal prognosis, unexpected poor prognosis, poor prognosis of advanced maternal age, or expected poor prognosis.
Exclusion Criteria
* 2\. Participation in cycles involving pre-implantation genetic testing or diagnosis of embryos;
* 3\. Involvement in cycles utilizing frozen gametes;
* 4\. Engagement in cycles that employ donor-derived oocytes;
* 5\. Participation in in vitro maturation cycles;
* 6.The presence of uterine cavity or endometrial abnormalities, including but not limited to fibroids, endometrial polyps, malformations, adenomyomas, endometritis, endometrial thinning, hydrosalpinx, uterine infections;
* 7.The existence of contraindications to assisted reproductive technology or pregnancy, such as uncontrolled liver or kidney dysfunction, diabetes mellitus (with glycated hemoglobin ≤ 7% and fasting blood glucose \&amp;amp;lt; 10 mmol/L), hypertension, thyroid disorders, asymptomatic cardiac conditions, moderate-to-severe anemia, malignancies, a history of thromboembolism or thrombosis, severe mental health disorders, acute infections of the urinary and reproductive systems, sexually transmitted infections, and detrimental lifestyle factors including substance abuse. Additionally, exposure to teratogenic levels of radiation, toxins, or medications (such as prednisone, other hormones, adrenaline, antibiotics, or medications for hypertension, cardiovascular issues, or antiviral treatment) during surgical procedures, as well as any physical conditions rendering pregnancy inadvisable, are also considered disqualifying factors.
20 Years
45 Years
FEMALE
Yes
Sponsors
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Shandong University of Traditional Chinese Medicine
OTHER
Responsible Party
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Jing-Yan Song
Doctor
Principal Investigators
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Zhen-Gao Sun, M.D
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Locations
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Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Cozzolino M, Herraiz S, Titus S, Roberts L, Romeu M, Peinado I, Scott RT, Pellicer A, Seli E. Transcriptomic landscape of granulosa cells and peripheral blood mononuclear cells in women with PCOS compared to young poor responders and women with normal response. Hum Reprod. 2022 May 30;37(6):1274-1286. doi: 10.1093/humrep/deac069.
Jiang Z, Shi C, Han H, Wang Y, Liang R, Chen X, Shen H. Mitochondria-related changes and metabolic dysfunction in low prognosis patients under the POSEIDON classification. Hum Reprod. 2021 Oct 18;36(11):2904-2915. doi: 10.1093/humrep/deab203.
Wang T, Cao Y, Zheng Q, Tu J, Zhou W, He J, Zhong J, Chen Y, Wang J, Cai R, Zuo Y, Wei B, Fan Q, Yang J, Wu Y, Yi J, Li D, Liu M, Wang C, Zhou A, Li Y, Wu X, Yang W, Chin YE, Chen G, Cheng J. SENP1-Sirt3 Signaling Controls Mitochondrial Protein Acetylation and Metabolism. Mol Cell. 2019 Aug 22;75(4):823-834.e5. doi: 10.1016/j.molcel.2019.06.008. Epub 2019 Jul 10.
Gershon E, Plaks V, Dekel N. Gap junctions in the ovary: expression, localization and function. Mol Cell Endocrinol. 2008 Jan 30;282(1-2):18-25. doi: 10.1016/j.mce.2007.11.001. Epub 2007 Nov 19.
Imanaka S, Shigetomi H, Kobayashi H. Reprogramming of glucose metabolism of cumulus cells and oocytes and its therapeutic significance. Reprod Sci. 2022 Mar;29(3):653-667. doi: 10.1007/s43032-021-00505-6. Epub 2021 Mar 5.
Richani D, Dunning KR, Thompson JG, Gilchrist RB. Metabolic co-dependence of the oocyte and cumulus cells: essential role in determining oocyte developmental competence. Hum Reprod Update. 2021 Jan 4;27(1):27-47. doi: 10.1093/humupd/dmaa043.
Gilchrist RB, Ritter LJ, Armstrong DT. Oocyte-somatic cell interactions during follicle development in mammals. Anim Reprod Sci. 2004 Jul;82-83:431-46. doi: 10.1016/j.anireprosci.2004.05.017.
Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.
Matzuk MM, Lamb DJ. The biology of infertility: research advances and clinical challenges. Nat Med. 2008 Nov;14(11):1197-213. doi: 10.1038/nm.f.1895. Epub 2008 Nov 6.
Other Identifiers
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SDUTCMPOSEIDONHQS
Identifier Type: -
Identifier Source: org_study_id
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