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A Randomized Double-Blind Placebo-Controlled Parallel Clinical Study on the Efficacy of the Kidney-Tonifying and Blood-Regulating Formula in Patients with Ovarian Insufficiency Undergoing IVF-ET.

A Randomized Double-Blind Placebo-Controlled Parallel Clinical Study on the Efficacy of the Kidney-Tonifying and Blood-Regulating Formula in Patients with Ovarian Insufficiency Undergoing IVF-ET.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000010
Enrollment
Unknown
Registered
2025-01-03
Start date
2024-10-23
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

poor ovarian response

Interventions

Control group:Placebo
Experimental group:Herbal decoction

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 42 Years

Inclusion criteria

Inclusion criteria: (1)Female aged between 35 and 42 years. (2)Regular menstrual cycle with a cycle length of 21 to 35 days. (3)Meets the second and fourth subgroups of the Poor Ovarian Response Evaluation (POSEIDON) criteria. (4)Planning to undergo IVF-ET with an antagonist protocol for ovarian stimulation. (5)Meets the diagnostic criteria for Kidney Deficiency according to Traditional Chinese Medicine. (6)Voluntarily agrees to participate in this clinical trial and signs a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Untreated hydrosalpinx endometriosis untreated uterine diseases (such as endometrial polyps intrauterine adhesions) or uterine fibroids larger than 4 cm. 2.History of recurrent implantation failure (defined as having undergone =3 transfers or having a total of 4-6 high-quality cleavage-stage embryos or =3 high-quality blastocysts that have failed). 3.BMI = 28 kg/m². 4.Abnormal liver or kidney function. 5.Male partner with severe or very severe oligospermia. 6.Not planning to undergo embryo transfer within six months. 7.Known allergy to the study medication. 8.Received Traditional Chinese Medicine treatment for poor ovarian response (such as Kuntai capsules Dingkun pills Tiaojing Chuyun pills Jinfeng pills Qilin pills or herbal decoctions containing Cuscuta Duhuo and Sangjisheng) within three months prior to enrollment. 9.Participated in other clinical trials within three months prior to enrollment. 10.Considered by the investigator to be unsuitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
number of oocytes retrieved;

Secondary

MeasureTime frame
Luteinizing hormone on HCG day;Total amount of gonadotropin;Antral Follicle Count;TCM syndrome curative effect;Good quality embryo rate;Natural pregnancy and menstruation during medication;LH;Uterine thickness;Progesterone on the day of HCG;Positive rate of serum HCG;Clinical pregnancy rate;Live birth rate;Number of follicles on HCG day;Biochemical pregnancy rate;AMH;P;Gonadotropin days;Endometrial thickness and type on HCG day;Cancel the cycle number/rate;Types of Uterus;Uterine and Ovarian size;FSH;Estradiol on HCG day;E2;

Countries

China

Contacts

Public ContactXiYan Xin

Peking University Third Hospital

xinxiyan198234@163.com13810947856

Outcome results

None listed

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