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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guidelines for Routine Treatment + Coenzyme Q10 | Experimental | Guidelines for Routine Treatment + Coenzyme Q10 (Nengqi Lang, Yunda Pharmaceutical) 30mg orally, 3 times daily, with pretreatment lasting 8 weeks. • ART treatment (in vitro fertilization (IVF)) commences during the first menstrual cycle following completion of treatment. |
|
| Guidelines for Routine Treatment plus placebo | Placebo Comparator | Guidelines for Routine Treatment plus placebo, administered for 8 weeks. ART treatment (IVF) commenced during the first menstrual cycle following completion of the treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coenzyme Q10 | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved | Total number of oocytes retrieved during the oocyte retrieval procedure(unit: count). | 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). | From the start of pretreatment until the IVF oocyte retrieval day (approximately 8 weeks of pretreatment plus one IVF treatment cycle). |
| Measure | Description | Time Frame |
|---|---|---|
| Total Gonadotropin (Gn) Dose | Total dosage of Gonadotropin (Gn) used during one IVF stimulation cycle (unit: International Units, IU). | From the start of ovarian stimulation until the HCG trigger day (up to approximately 2 weeks). |
| Days of stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Reactions | The incidence of adverse events occurring during the treatment period. | From the first dose of the study drug until 6 weeks after the first embryo transfer (for clinical pregnancy assessment). |
Inclusion Criteria:
or
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongya Yang | Contact | +8615229271287 | 42352576@qq.com |
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| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
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| Placebo | Dietary Supplement | Drug A plus placebo, administered for 8 weeks. ART treatment (IVF) commenced during the first menstrual cycle following completion of the treatment. |
|
Total number of days from the initiation of Gonadotropin (Gn) to the HCG trigger day in one IVF cycle (unit: days). |
| 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). | 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). | 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. | 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. | Day 1 after oocyte retrieval (fertilization assessment) |
| Cleavage Rate | The percentage of fertilized oocytes that undergo cleavage out of the total fertilized oocytes. | 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. | 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. | 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. | From confirmation of clinical pregnancy until 20 weeks of gestation. |