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Therapeutic Efficacy of Intravenous Coenzyme I in Patients with Age-Related Ovarian Insufficiency

Therapeutic Efficacy of Intravenous Coenzyme I in Patients with Age-Related Ovarian Insufficiency

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105206
Enrollment
Unknown
Registered
2025-06-30
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Age-Related Diminished Ovarian Reserve

Interventions

Control Group:Placebo
Coenzyme I Intramuscular Injection Group:Injectable Coenzyme I is administered by intramuscular injection at a dose of 5 mg per administration, once daily. A 12-week period constitutes one course of t
Coenzyme I Intravenous Infusion Group:Injectable Coenzyme I is administered by intravenous infusion at a dose of 50 mg per administration, once daily. A 14-day period constitutes one course of treatme

Sponsors

Qinzhou Maternity and Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=35 years; 2. Comply with IVF/ICSI indications; 3. Body mass index (BMI) >=18 kg/m^2 and <=38 kg/m^2; 4.AMH < 1.2 ng/ml; 5. Sinus follicle count (AFC) < 7; 6. 10 mIU/ml < FSH < 25 mIU/ml; 7. Agree to participate in this study and be willing to complete follow-up visits.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Premature ovarian failure due to genetic causes: such as Turner syndrome or chromosomal abnormalities; 3. Underlying diseases: blood diseases, significant thrombocytopenia, diabetes, hypertension, thyroid diseases, thrombotic diseases, tumor diseases, autoimmune diseases; 4. Uterine malformations or lesions (such as submucosal fibroids, endometrial hyperplasia, endometrial effusion or endometrial adhesions, thin endometrium); 5. Male oligoasthenospermia or azoospermia; 6. Those who are allergic to Coenzyme I and its derivatives; 7. Those who have other contraindications to assisted reproductive technology.

Design outcomes

Primary

MeasureTime frame
Number of oocytes retrieved;

Secondary

MeasureTime frame
Number of MII oocytes;Number of MI oocytes;Number of GV oocytes;Number of other abnormal oocytes;Number of embryos obtained;Number of viable embryos;Number of transferable embryos;Number of cryopreserved embryos;Number of embryos cultured to blastocyst;Number of blastocysts formed;Number of cryopreserved blastocysts;Number of high-quality blastocysts;Biochemical pregnancy rate;Clinical pregnancy rate;Ectopic pregnancy rate;Combined intrauterine and extrauterine pregnancy rate;Early miscarriage rate;

Countries

China

Contacts

Public ContactHongBo Wu

Qinzhou Maternity and Child Healthcare Hospital

wuhongbo20212021@163.com+86 777 239 3588

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026