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

NCT07260773 | Not Yet Recruiting DMC

• 1 other identifier: 202507-08
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ovarian Response

Keywords

Ovarian function

Outcome Measures

Primary Outcomes (2)

• 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).

Secondary Outcomes (10)

• Total Gonadotropin (Gn) Dose

  From the start of ovarian stimulation until the HCG trigger day (up to approximately 2 weeks).

• Days of stimulation

  From the start of ovarian stimulation until the HCG trigger day (up to approximately 2 weeks).

• Peak Estradiol (E2) Level

  Assessed on the HCG trigger 1 day.

• Cycle Cancellation Rate

  From the start of ovarian stimulation until the scheduled oocyte retrieval day (up to approximately 2 weeks).

• Fertilization rate

  Day 1 after oocyte retrieval (fertilization assessment)

Other Outcomes (1)

• Incidence of Adverse Reactions

  From the first dose of the study drug until 6 weeks after the first embryo transfer (for clinical pregnancy assessment).

Study Arms (2)

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.

Dietary Supplement: Coenzyme Q10

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.

Dietary Supplement: Placebo

Interventions

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.

Guidelines for Routine Treatment plus placebo

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.

Guidelines for Routine Treatment + Coenzyme Q10

Eligibility Criteria

• Age: 20 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• (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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Tang-Du Hospital: lead

MeSH Terms

Interventions

coenzyme Q10

Central Study Contacts

Hongya Yang

CONTACT

+8615229271287; 42352576@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Obstetrics and Gynecology, Tangdu Hospital, Air Force Medical University Director of the Reproductive Medicine Center

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share