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Observation of the clinical application of Heyan Kuntai Capsules in patients with decreased ovarian reserve undergoing in vitro fertilization-embryo transfer treatment.

Observation of the clinical application of Heyan Kuntai Capsules in patients with decreased ovarian reserve and undergoing in vitro fertilization-embryo transfer treatment.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073418
Enrollment
Unknown
Registered
2023-07-11
Start date
2023-07-11
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

Diminished Ovarian Reserve,Poor ovarian response

Interventions

treatment group:Heyan Kuntai capsule
control group:Recombinant human growth hormone injection

Sponsors

The First Affiliated Hospital of University of Science and Technology of China(Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 43 Years

Inclusion criteria

Inclusion criteria: 1) Women aged 25 to 43 years old; 2) Meeting the diagnostic criteria for infertility; 3) Meeting the diagnostic criteria for decreased ovarian reserve; 4) Meeting the diagnostic criteria for poor ovarian response; 5) Willing to sign an informed consent form and voluntarily participate in the trial. Note: Participants must meet conditions 1, 2, and 5, and also meet either condition 3 or 4 to be eligible for inclusion.

Exclusion criteria

Exclusion criteria: 1)Patients with ovarian insufficiency, defined as amenorrhea for =4 months or FSH>25U/L; 2)Untreated uterine anomalies: double uterus, septate uterus (complete or incomplete); untreated uterine diseases: intrauterine adhesions, endometriosis, adenomyosis, uterine endometrial lesions (submucosal fibroids, endometrial polyps, etc.), uterine fibroids > 4cm; 3)History of pelvic radiation or chemotherapy; 4)Patients with a body mass index (BMI) > 28kg/m2; 5)Male partners with severe oligoasthenoteratozoospermia; 6)Recent use (within the past 2 weeks) of herbal and Chinese medicine, hormonal medications, or known allergies to the study drugs (see Appendix 6); 7)Patients with severe primary diseases affecting the cardiovascular, liver, kidney, hematopoietic systems, or mental illness; 8)Other patients deemed unsuitable for participation in the study by the investigators. Note: Participants must meet at least one of the criteria from 1 to 8 to be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Number of oocytes retrieved;

Secondary

MeasureTime frame
basal serum sex hormones;Antral follicle count;Anti-Müllerian hormone;Endometrial thickness;Kupperman Index;Traditional Chinese Medicine syndrome score ;Serum estradiol levels on HCG day;Gonadotropin (Gn) total dose used;Number of days of use of Gn;Number/rate of cancellation cycles;Number of MII oocytes;Number/rate of fertilized eggs;Number of 2 pronuclei (PN) fertilizations;Number/rate of blastocysts;Number/rate of D3 high-quality embryos;Number/rate of D3 embryos;clinical pregnancy rate;

Countries

China

Contacts

Public ContactLuan Hongbing

The First Affiliated Hospital of University of Science and Technology of China

luananhui@163.com+86 181 1091 7843

Outcome results

None listed

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