The Effects of Coenzyme Q10 Pretreatment on Ovarian Function and Assisted Reproductive Outcomes in Patients With Ovarian Hyporesponsiveness.

Official title

The Effects of Coenzyme Q10 Pretreatment on Ovarian Function and Assisted Reproductive Outcomes in Patients With Poor Ovarian Response: A Single-Center Randomized Controlled Trial

Overview

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.

Detailed description

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.

Interventions

• Dietary supplement Coenzyme Q10
  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.
• Dietary supplement Placebo
  Drug A plus placebo, administered for 8 weeks. ART treatment (IVF) commenced during the first menstrual cycle following completion of the treatment.

Primary outcome measures

• Number of oocytes retrieved [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 [Time frame: From the start of pretreatment until the IVF oocyte retrieval day (approximately 8 weeks of pretreatment plus one IVF treatment cycle).]

Secondary outcome measures (10)

• Total Gonadotropin (Gn) Dose [Time frame: From the start of ovarian stimulation until the HCG trigger day (up to approximately 2 weeks).]
• Days of stimulation [Time frame: From the start of ovarian stimulation until the HCG trigger day (up to approximately 2 weeks).]
• Peak Estradiol (E2) Level [Time frame: Assessed on the HCG trigger 1 day.]
• Cycle Cancellation Rate [Time frame: From the start of ovarian stimulation until the scheduled oocyte retrieval day (up to approximately 2 weeks).]
• Fertilization rate [Time frame: Day 1 after oocyte retrieval (fertilization assessment)]
• Normal fertilization rate [Time frame: Day 1 after oocyte retrieval (fertilization assessment)]
• Cleavage Rate [Time frame: Day 3 after oocyte retrieval (embryo development assessment)]
• Day 3 High-Quality Embryo Rate [Time frame: Day 3 after oocyte retrieval (embryo morphology scoring)]
• Clinical Pregnancy Rate (First Transfer Cycle) [Time frame: From pretreatment initiation until 6 weeks after the first embryo transfer.]
• Miscarriage Rate [Time frame: From confirmation of clinical pregnancy until 20 weeks of gestation.]

Eligibility criteria

Inclusion criteria

• Individuals seeking IVF-ET fertility treatment;
• Meeting the Bologna criteria for the definition of poor ovarian response (POR), specifically:
• (1) Meeting 2 of the following 3 criteria:
• ① Presence of high-risk factors for POR;
• ② Previous cycle with ≤3 retrieved oocytes under a standard stimulation protocol;
• ③ Abnormal ovarian reserve assessment: Antral follicle count (AFC) <5 or Anti-Müllerian hormone (AMH) <1.1 ng/mL.

or

• (2) Patients with normal age or ovarian reserve function who experience poor ovarian response (POR) after two consecutive cycles of maximum ovarian stimulation protocols;
• BMI between 18.5-28.0 kg/m²
• Voluntarily participate and sign an informed consent form.

Exclusion criteria

• Age ≥40 years;
• Baseline FSH >25 U/L;
• Endocrine disorders (e.g., diabetes, thyroid disease) or autoimmune diseases (e.g., rheumatoid arthritis, lupus, Crohn's disease), chromosomal abnormalities, uterine malformations;
• History of ovarian surgery; history of uterine surgery; adenomyosis;
• History of more than 3 cycles of controlled ovarian stimulation (COS);
• Male infertility;
• Use within the past 3 months of medications that may affect ovarian reserve or ovarian responsiveness (e.g., oral contraceptives, glucocorticoids, antioxidant supplements, insulin sensitizers, DHEA, growth hormone, etc.);
• Use of traditional Chinese medicine within the past 3 months;
• Known allergy to Coenzyme Q10 or panthenol (water-soluble isomer of CoQ10);
• PGT (Preimplantation Genetic Testing) population;
• Acute or chronic renal insufficiency, hemodialysis treatment, history of severe renal impairment;
• Infectious diseases such as HIV, active hepatitis, history of metabolic acidosis, tuberculosis;
• Cardiovascular events within 3 months: coronary artery disease/myocardial infarction/clinically significant congestive heart failure; stroke/transient ischemic attack; deep vein thrombosis/pulmonary embolism; uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥90 mmHg); diagnosed diabetes; coronary intervention or coronary artery bypass graft surgery;
• Neurological disorders such as dementia (e.g., Alzheimer's/Parkinson's) or use of related medications;
• History of psychological/psychiatric disorders and use of antiepileptic, antidepressant, or similar medications;
• History of cancer, radiation therapy, or chemotherapy;
• Unwillingness to take supplements provided by this study;
• Alcoholics, smokers, or individuals with substance dependence;
• Participants in other clinical trials within the past month;
• Patients deemed ineligible for enrollment by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07260773 · 202507-08

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗