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

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06617988
Acronym
POR SIRT3
Enrollment
80
Registered
2024-10-01
Start date
2024-11-15
Completion date
2025-09-15
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Ovarian Response

Keywords

Poor ovarian response, In vitro fertilization and embryo transfer, Sirtuin-3, mRNA expression

Brief 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. 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.

Interventions

OTHERNot applicable- observational study

Not applicable- observational study

Sponsors

Shandong University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The relative expression level of SIRT3 mRNA of granulosa cellsDetected within three days after oocyte retrievalThe real-time quantitative PCR methods were used to test the relative expression level of SIRT3 mRNA of granulosa cells of each participant among groups.

Secondary

MeasureTime frameDescription
Positive pregnancy rate2 weeks after the day of embryo transferSerum β-hCG level ≥ 10mIU/mL, 14 days after embryo transfer. \[Detected via ELISA\]
Embryo implantation rate3 weeks after the day of embryo transferThe number of intrauterine gestational sacs observed divided by the number of embryos transferred. \[Detected via ultrasound\]
Clinical pregnancy rate4 weeks after the day of embryo transferAn intrauterine gestational sac with fetal heartbeat detected by transvaginal ultrasonography. \[Detected via ultrasound\]
Number of oocytes retrievedWithin 1 day after the oocyte retrievalThe total number of oocytes retrieved in the In Vitro Fertilization and Embryo transfer cycle.
Average daily dose of gonadotropin per COS cycleThrough the process of controlled ovarian stimulation, an average of 10 daysAverage daily dose of gonadotropin per COS cycle
Total dosage of gonadotropin per COS cycleThrough the process of controlled ovarian stimulation, an average of 10 daysTotal dosage of gonadotropin per COS cycle

Countries

China

Contacts

PRINCIPAL_INVESTIGATORZhen-Gao Sun, M.D

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026