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

ConditionOvarian Response
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-39
SponsorTang-Du Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals seeking IVF-ET fertility treatment;

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Guidelines for Routine Treatment + Coenzyme Q10Experimental treatment 1 intervention
Group B: Guidelines for Routine Treatment plus placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of oocytes retrieved

Total number of oocytes retrieved during the oocyte retrieval procedure(unit: count).

Time frame
From the start of pretreatment until the IVF oocyte retrieval day (approximately 8 weeks of pretreatment plus one IVF treatment cycle).
2

Rate of Metaphase II (MII) Oocytes

The proportion of mature oocytes (Metaphase II oocytes) among the total number of oocytes retrieved (unit: percentage).

Time frame
From the start of pretreatment until the IVF oocyte retrieval day (approximately 8 weeks of pretreatment plus one IVF treatment cycle).

Secondary outcomes

1

Total Gonadotropin (Gn) Dose

Total dosage of Gonadotropin (Gn) used during one IVF stimulation cycle (unit: International Units, IU).

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

Days of stimulation

Total number of days from the initiation of Gonadotropin (Gn) to the HCG trigger day in one IVF cycle (unit: days).

Time frame
From the start of ovarian stimulation until the HCG trigger day (up to approximately 2 weeks).
3

Peak Estradiol (E2) Level

Serum estradiol level measured on the day of HCG trigger (unit: pg/mL).

Time frame
Assessed on the HCG trigger 1 day.
4

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).

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

Other outcomes

1

Incidence of Adverse Reactions

The incidence of adverse events occurring during the treatment period.

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tang-Du Hospital

Lead sponsor

Source ClinicalTrials.gov

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