Poor Ovarian ResponsePOR SIRT3NCT06617988
SIRT3 Expression in Granulosa Cells and the Levels of Follicular Fluid Metabolites Among POR Subgroups
An observational study of Poor Ovarian Response, run by Shandong University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The goal of this prospective, observational study is to learn about the pathogenesis and biological target of the subtypes of poor ovarian response (POR) during In vitro fertilization and embryo transfer (IVF-ET). The main question it aims to answer is: 1. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poor Ovarian Response
- What is being tested?
- Not applicable- observational study
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2024to 15 Sep 2025
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study cohort will prospectively enroll women undergoing in vitro fertilization and embryo transfer (IVF-ET) treatment at the Department of Reproduction and Genetics, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, from October 2024 to January 2025. This cohort will be stratified into four study groups based on the following criteria in equal proportions. All participants will receive the standard operation protocol for In vitro fertilization and embryo transfer.
Who may be able to join
- 1. Women who are married and aged between 20 to 45 years, diagnosed with infertility;
- 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.
Who cannot join
- 1. A body mass index (BMI) of ≥ 35 kg/m²;
- 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 \< 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250011
About this study
Official title: Investigate Differences in SIRT3 Expression in Granulosa Cells and the Levels of Follicular Fluid Metabolites Among Poor Ovarian Responders Subgroups, and Their Association With IVF Outcomes.
The goal of this prospective, observational study is to learn about the pathogenesis and biological target of the subtypes of poor ovarian response (POR) during In vitro fertilization and embryo transfer (IVF-ET). The main question it aims to answer is:
- Can the relative expression level of SIRT3 differentiate between POR subtypes, and do these differences reflect distinct metabolic characteristics among the subtypes?
- 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.
- Conditions
- Poor Ovarian Response
- Being tested
- Not applicable- observational study
- Keywords
- Poor ovarian response, In vitro fertilization and embryo transfer, Sirtuin-3, mRNA expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: 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. Receives: Other: 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. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative expression level of SIRT3 mRNA of granulosa cells
The real-time quantitative PCR methods were used to test the relative expression level of SIRT3 mRNA of granulosa cells of each participant among groups.
Measured: Detected within three days after oocyte retrieval
Secondary outcomes (6)
Positive pregnancy rate
Serum β-hCG level ≥ 10mIU/mL, 14 days after embryo transfer. [Detected via ELISA]
Measured: 2 weeks after the day of embryo transfer
Embryo implantation rate
The number of intrauterine gestational sacs observed divided by the number of embryos transferred. [Detected via ultrasound]
Measured: 3 weeks after the day of embryo transfer
Clinical pregnancy rate
An intrauterine gestational sac with fetal heartbeat detected by transvaginal ultrasonography. [Detected via ultrasound]
Measured: 4 weeks after the day of embryo transfer
Number of oocytes retrieved
The total number of oocytes retrieved in the In Vitro Fertilization and Embryo transfer cycle.
Measured: Within 1 day after the oocyte retrieval
Average daily dose of gonadotropin per COS cycle
Average daily dose of gonadotropin per COS cycle
Measured: Through the process of controlled ovarian stimulation, an average of 10 days
Total dosage of gonadotropin per COS cycle
Total dosage of gonadotropin per COS cycle
Measured: Through the process of controlled ovarian stimulation, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start15 Nov 2024
- Primary completion18 Jan 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Poor Ovarian ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Shandong University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing-Yan Song, Shandong University of Traditional Chinese Medicine
- Investigators
- Zhen-Gao Sun, M.D, Principal investigator, Affiliated Hospital of Shandong University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617988
- Sponsor's protocol ID
- SDUTCMPOSEIDONHQS
- Acronym
- POR SIRT3
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31302001Gershon 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.
PubMed 18162286Imanaka 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.
PubMed 33675030Richani 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.
PubMed 33020823Gilchrist 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.
PubMed 15271471Poseidon 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.
PubMed 26921622Matzuk 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.
PubMed 18989307Cozzolino 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.
PubMed 35451009Jiang 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.
PubMed 34545401
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate Differences in SIRT3 Expression in Granulosa Cells and the Levels of Follicular Fluid Metabolites Among Poor Ovarian Responders Subgroups, and Their Association With IVF Outcomes.
- ClinicalTrials.gov ID
- NCT06617988
- Acronym / sponsor ID
- POR SIRT3 / SDUTCMPOSEIDONHQS
- Conditions
- Poor Ovarian Response
- Keywords
- Poor ovarian response, In vitro fertilization and embryo transfer, Sirtuin-3, mRNA expression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shandong University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 18 Jan 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective, observational study is to learn about the pathogenesis and biological target of the subtypes of poor ovarian response (POR) during In vitro fertilization and embryo transfer (IVF-ET). The main question it aims to answer is:
- Can the relative expression level of SIRT3 differentiate between POR subtypes, and do these differences reflect distinct metabolic characteristics among the subtypes?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal prognosis group (control group) | – | Other: Not applicable- observational studyParticipants 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. |
| Unexpected poor prognosis group | – | Other: Not applicable- observational studyParticipants 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. |
| Poor prognosis of advanced maternal age group | – | Other: Not applicable- observational studyParticipants 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. |
| Expected poor prognosis group | – | Other: Not applicable- observational studyParticipants 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study cohort will prospectively enroll women undergoing in vitro fertilization and embryo transfer (IVF-ET) treatment at the Department of Reproduction and Genetics, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, from October 2024 to January 2025. This cohort will be stratified into four study groups based on the following criteria in equal proportions. All participants will receive the standard operation protocol for In vitro fertilization and embryo transfer.
Key inclusion criteria (3 listed)
- 1. Women who are married and aged between 20 to 45 years, diagnosed with infertility;
- 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.
Key exclusion criteria (7 listed)
- 1. A body mass index (BMI) of ≥ 35 kg/m²;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | Expected poor prognosis group, Normal prognosis group (control group), Poor prognosis of advanced maternal age group, Unexpected poor prognosis group |
Primary outcome
The relative expression level of SIRT3 mRNA of granulosa cells
Time frame: Detected within three days after oocyte retrieval
The real-time quantitative PCR methods were used to test the relative expression level of SIRT3 mRNA of granulosa cells of each participant among groups.
6 secondary outcomes
Positive pregnancy rate
Time frame: 2 weeks after the day of embryo transfer
Embryo implantation rate
Time frame: 3 weeks after the day of embryo transfer
Clinical pregnancy rate
Time frame: 4 weeks after the day of embryo transfer
Number of oocytes retrieved
Time frame: Within 1 day after the oocyte retrieval
Average daily dose of gonadotropin per COS cycle
Time frame: Through the process of controlled ovarian stimulation, an average of 10 days
Total dosage of gonadotropin per COS cycle
Time frame: Through the process of controlled ovarian stimulation, an average of 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 31302001Wang 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.
- Background: PubMed 18162286Gershon 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.
- Background: PubMed 33675030Imanaka 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.
- Background: PubMed 33020823Richani 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.
- Background: PubMed 15271471Gilchrist 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.
- Background: PubMed 26921622Poseidon 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.
- Background: PubMed 18989307Matzuk 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.
- Results publication: PubMed 35451009Cozzolino 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.
- Results publication: PubMed 34545401Jiang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen-Gao Sun, M.D principal investigator
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Ovarian Response, run by Shandong University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relative expression level of SIRT3 mRNA of granulosa cells (time frame: Detected within three days after oocyte retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06617988, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.