Ovarian ResponseNCT07260773
The Effects of Coenzyme Q10 Pretreatment on Ovarian Function and Assisted Reproductive Outcomes in Patients With Ovarian Hyporesponsiveness.
A study testing Coenzyme Q10 in people with Ovarian Response, run by Tang-Du Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Ovarian Response
- What is being tested?
- Coenzyme Q10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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
- Being tested
- Coenzyme Q10, Placebo
- Keywords
- Ovarian function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Dietary 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.
PlaceboDietary supplement
Drug A plus placebo, administered for 8 weeks. ART treatment (IVF) commenced during the first menstrual cycle following completion of the treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
Total number of oocytes retrieved during the oocyte retrieval procedure(unit: count).
Measured: 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).
Measured: 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
Total dosage of Gonadotropin (Gn) used during one IVF stimulation cycle (unit: International Units, IU).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 1 after oocyte retrieval (fertilization assessment)
Cleavage Rate
The percentage of fertilized oocytes that undergo cleavage out of the total fertilized oocytes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From confirmation of clinical pregnancy until 20 weeks of gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study startJul 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian ResponseStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohong Wang, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260773
- Sponsor's protocol ID
- 202507-08
- Status last verified
- May 2026
- First submitted
- 30 Sep 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07260773
- Acronym / sponsor ID
- 202507-08
- Conditions
- Ovarian Response
- Keywords
- Ovarian function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guidelines for Routine Treatment + Coenzyme Q10 | Experimental | Dietary Supplement: Coenzyme Q10Guidelines 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 | Dietary Supplement: PlaceboGuidelines for Routine Treatment plus placebo, administered for 8 weeks. ART treatment (IVF) commenced during the first menstrual cycle following completion of the treatment. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (20 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coenzyme Q10One 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 | Guidelines for Routine Treatment + Coenzyme Q10 |
| PlaceboDrug A plus placebo, administered for 8 weeks. ART treatment (IVF) commenced during the first menstrual cycle following completion of the treatment. | Dietary supplement | Guidelines for Routine Treatment plus placebo |
Primary outcome
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).
Total number of oocytes retrieved during the oocyte retrieval procedure(unit: count).
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).
The proportion of mature oocytes (Metaphase II oocytes) among the total number of oocytes retrieved (unit: percentage).
10 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 in people with Ovarian Response, run by Tang-Du Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongya Yang (+8615229271287, 42352576@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.