SIRT3 Expression in Granulosa Cells and the Levels of Follicular Fluid Metabolites Among POR Subgroups (POR SIRT3)

April 23, 2026 updated by: Jing-Yan Song, Shandong University of Traditional Chinese Medicine

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:

  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250011
        • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.
Other: 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.
Other: 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.
Other: Not applicable- observational study
Not applicable- observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Detected within three days after oocyte retrieval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive pregnancy rate
Time Frame: 2 weeks after the day of embryo transfer
Serum β-hCG level ≥ 10mIU/mL, 14 days after embryo transfer. [Detected via ELISA]
2 weeks after the day of embryo transfer
Embryo implantation rate
Time Frame: 3 weeks after the day of embryo transfer
The number of intrauterine gestational sacs observed divided by the number of embryos transferred. [Detected via ultrasound]
3 weeks after the day of embryo transfer
Clinical pregnancy rate
Time Frame: 4 weeks after the day of embryo transfer
An intrauterine gestational sac with fetal heartbeat detected by transvaginal ultrasonography. [Detected via ultrasound]
4 weeks after the day of embryo transfer
Number of oocytes retrieved
Time Frame: Within 1 day after the oocyte retrieval
The total number of oocytes retrieved in the In Vitro Fertilization and Embryo transfer cycle.
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
Average daily dose of gonadotropin per COS cycle
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
Total dosage of gonadotropin per COS cycle
Through the process of controlled ovarian stimulation, an average of 10 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of follicular fluid metabolites
Time Frame: Detected within three days after oocyte retrieval
Patients will be randomly selected from each group and the levels of metabolites (including lactate, pyruvate, malondialdehyde, glutathione) in the follicular fluid will be measured using the corresponding kits.
Detected within three days after oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Zhen-Gao Sun, M.D, Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2024

Primary Completion (Actual)

January 18, 2025

Study Completion (Actual)

September 15, 2025

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SDUTCMPOSEIDONHQS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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