NCT07260773

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 39 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Ovarian Response

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-12-03
• Last updated: 2025-12-05