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A multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of Zishen Yutai Pill on IVF outcomes in young women with expected ovarian hyporesponsiveness (Poseidon Group 3) and explore the mechanism of follicular fluid metabolism

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of Zishen Yutai Pill on IVF outcomes in young women with expected ovarian hyporesponsiveness (Poseidon Group 3) and explore the mechanism of follicular fluid metabolism

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079332
Enrollment
Unknown
Registered
2024-01-01
Start date
2024-01-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

infertility

Interventions

intervention:Zishen Yutai Pill treatment+GnRH antagonist protocol
control:GnRH antagonist protocol

Sponsors

Affiliated Hospital of Shandong University of Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 34 Years

Inclusion criteria

Inclusion criteria: (1) Women aged = 20 years old,<35 years old, married and diagnosed as infertile; (2) Planned IVF/ICSI treatment; (3) Low ovarian reserve (anti Mullerian hormone (AMH) levels<1.2 ng/ml and/or antral follicle count (AFC)<5).

Exclusion criteria

Exclusion criteria: (1) Age = 35 years old; (2) Body mass index (BMI) = 35 kg/m2; (3) donor oocyte recipient cycles or in vitro maturation (IVM) or blastocyst biopsy for preimplantation genetic diagnosis (PGD) or preimplantation genetic testing for aneuploidy (PGT-A); (4) Congenital or acquired abnormalities in the anatomical structure of the uterus; (5) Abnormal heart, liver, and kidney function or accompanied by serious mental problems; (6) Persons who are allergic to the test drug; (7) Suffering from diseases that are not suitable for pregnancy or for assisted reproductive therapy; (8) Patients who have used Chinese medicine in the past three months, including acupuncture and moxibustion and Chinese herbal medicine.

Design outcomes

Primary

MeasureTime frame
number of oocytes retrieved;—

Secondary

MeasureTime frame
Duration of use of exogenous gonadotropins;total exogenous gonadotropin dose;average daily dose of exogenous gonadotropins;Serum E2 (pg/ml) and P (ng/ml) levels on the trigger day;fertilization number;Number of transferable embryos;Number of top quality embryos (TQE);Mature oocyte rate (M ? oocyte rate);Cycle cancellation rate;positive pregnancy test;implantation rate;clinical pregnancy;Early spontaneous abortion ;threatened abortion;ectopic pregnancy;Multiple pregnancy ;Persistent pregnancy;—

Countries

China

Contacts

Public ContactSun Zhengao

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

sunzhengao77@163.com+86 137 0893 8621

Outcome results

None listed

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