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NCT Number: NCT06617988

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

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250011, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Not applicable- observational study

Other

Not applicable- observational study

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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. 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. 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.

  5. 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

  6. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shandong University of Traditional Chinese Medicine

Other

Registry information

Official study 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.

Acronym: POR SIRT3

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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