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

Not yet recruiting

• Conditions: Poor Ovarian Response
• Interventions: Other: Not applicable- observational study

• Registration Number: NCT06617988
• Lead Sponsor: Shandong University of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30
• Study Start: 2024-10-15
• Primary Completion: 2025-01-18
• Study Completion: 2025-02-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Poor prognosis of advanced maternal age group	Not applicable- observational study	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.
Expected poor prognosis group	Not applicable- observational study	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.
Normal prognosis group (control group)	Not applicable- observational study	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.
Unexpected poor prognosis group	Not applicable- observational study	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.

Primary Outcome Measures

Name	Time	Method
The relative expression level of SIRT3 mRNA of granulosa cells	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 Outcome Measures

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

Trial Locations

Locations (1)

Affiliated Hospital of Shandong University of Traditional Chinese Medicine; 🇨🇳 Jinan, Shandong, China