This prospective, randomized, double-blind, controlled study will be conducted at Tangdu Hospital, Air Force Medical University. It plans to enroll 128 patients with poor ovarian response for a 2-year study. The primary objective is to investigate the effects of exogenous coenzyme Q10 supplementation as pre-treatment on ovarian function and assisted reproductive clinical outcomes in patients with poor ovarian response. Study Hypothesis: Coenzyme Q10 therapy is expected to effectively enhance ovarian function and improve assisted reproductive outcomes in patients with poor ovarian response, while demonstrating favorable safety profiles.
This study is a prospective, randomized, double-blind, controlled clinical trial designed to investigate the effects of coenzyme Q10 pretreatment on ovarian function and assisted reproductive clinical outcomes in patients with poor ovarian response (POR). The study will be conducted at Tangdu Hospital, Air Force Medical University, with an anticipated enrollment of 128 patients meeting the Bologna diagnostic criteria for POR. Participants will be randomly assigned to either the study group (Coenzyme Q10 group) or the control group (placebo group), with 64 patients in each group. Study Group: Guidelines for Routine Treatment + Coenzyme Q10 (Nengqilang, Yuanda Pharmaceutical) 30mg orally, 3 times/day, for 8 weeks of pretreatment. ART treatment (in vitro fertilization (IVF)) commenced in the first menstrual cycle following completion of pretreatment. Control Group: Guidelines for Routine Treatment + placebo for 8 weeks. ART (IVF) initiated in the first menstrual cycle following treatment completion. Primary endpoints included oocyte retrieval rate and MII oocyte rate. Secondary endpoints encompassed total GnRHA dose, stimulation duration, peak E2 level, cycle cancellation rate, fertilization rate, high-quality embryo rate, clinical pregnancy rate, and miscarriage rate. Safety was assessed by adverse reaction incidence. The study aims to validate the efficacy and safety of Coenzyme Q10 in improving ovarian response and ART outcomes in patients with poor ovarian response through scientifically rigorous design and statistical analysis. This will provide reliable evidence-based medical support for clinical practice and contribute to enhancing women's reproductive health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
128
One group received coenzyme Q10 pretreatment, while the other group did not. Following an 8-week pretreatment period, IVF cycles were performed, with regular follow-up evaluations conducted.
Drug A plus placebo, administered for 8 weeks. ART treatment (IVF) commenced during the first menstrual cycle following completion of the treatment.
Number of oocytes retrieved
Total number of oocytes retrieved during the oocyte retrieval procedure(unit: count).
Time frame: From the start of pretreatment until the IVF oocyte retrieval day (approximately 8 weeks of pretreatment plus one IVF treatment cycle).
Rate of Metaphase II (MII) Oocytes
The proportion of mature oocytes (Metaphase II oocytes) among the total number of oocytes retrieved (unit: percentage).
Time frame: From the start of pretreatment until the IVF oocyte retrieval day (approximately 8 weeks of pretreatment plus one IVF treatment cycle).
Total Gonadotropin (Gn) Dose
Total dosage of Gonadotropin (Gn) used during one IVF stimulation cycle (unit: International Units, IU).
Time frame: From the start of ovarian stimulation until the HCG trigger day (up to approximately 2 weeks).
Days of stimulation
Total number of days from the initiation of Gonadotropin (Gn) to the HCG trigger day in one IVF cycle (unit: days).
Time frame: From the start of ovarian stimulation until the HCG trigger day (up to approximately 2 weeks).
Peak Estradiol (E2) Level
Serum estradiol level measured on the day of HCG trigger (unit: pg/mL).
Time frame: Assessed on the HCG trigger 1 day.
Cycle Cancellation Rate
The proportion of cycles cancelled due to poor ovarian response (e.g., inadequate follicular development) without proceeding to oocyte retrieval (unit: percentage).
Time frame: From the start of ovarian stimulation until the scheduled oocyte retrieval day (up to approximately 2 weeks).
Fertilization rate
The percentage of fertilized oocytes out of the total number of retrieved oocytes.
Time frame: Day 1 after oocyte retrieval (fertilization assessment)
Normal fertilization rate
The percentage of fertilized oocytes with two pronuclei (2PN) out of the total fertilized oocytes.
Time frame: Day 1 after oocyte retrieval (fertilization assessment)
Cleavage Rate
The percentage of fertilized oocytes that undergo cleavage out of the total fertilized oocytes.
Time frame: Day 3 after oocyte retrieval (embryo development assessment)
Day 3 High-Quality Embryo Rate
The percentage of high-quality embryos on Day 3 out of all Day 3 embryos.
Time frame: Day 3 after oocyte retrieval (embryo morphology scoring)
Clinical Pregnancy Rate (First Transfer Cycle)
The percentage of cycles with a gestational sac and fetal cardiac activity observed via transvaginal ultrasound approximately 5 weeks after the first embryo transfer, out of the total number of first transfer cycles.
Time frame: From pretreatment initiation until 6 weeks after the first embryo transfer.
Miscarriage Rate
The percentage of cycles with pregnancy loss after clinical confirmation of pregnancy out of all clinically pregnant cycles.
Time frame: From confirmation of clinical pregnancy until 20 weeks of gestation.
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