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Effect of Zishen Yutai Pill on Live Birth Rates in Frozen-Thawed Embryo Transfer Cycles Among Women of Advanced Maternal Age (ZYPHFETAL): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Effect of Zishen Yutai Pill on Live Birth Rates in Frozen-Thawed Embryo Transfer Cycles Among Women of Advanced Maternal Age (ZYPHFETAL): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001029
Enrollment
Unknown
Registered
2026-04-20
Start date
2026-05-15
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Advanced Maternal Age Infertility

Interventions

Intervention Group:Zishen Yutai Pill
Control group:Placebo

Sponsors

Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
35 Years to 44 Years

Inclusion criteria

Inclusion criteria: (1) Age between 35 and 44 years old (inclusive of 35, exclusive of 44); (2) History of = 2 embryo transfer cycles, planning for FET; (3) At least one transferable cleavage-stage embryo or blastocyst available.

Exclusion criteria

Exclusion criteria: (1) Body Mass Index (BMI) = 28 kg/m2; (2) History of recurrent miscarriage (= 2 times); (3) Congenital malformation of reproductive organs or acquired organic lesions; (4) Untreated hydrosalpinx, endometrial polyps, or intrauterine adhesions; (5) Chromosomal structural or numerical abnormalities, or a history of genetic diseases; (6) Use of other traditional Chinese medicine or steroidal hormones within the past three months; (7) Concomitant severe heart, liver, kidney disease, or other systemic diseases; (8) Allergy to any component of the study medication.

Design outcomes

Primary

MeasureTime frame
Live Birth Rate;

Secondary

MeasureTime frame
Positive Pregnancy;Embryo Implantation Rate;Clinical Pregnancy;Pregnancy Loss Rate;Pregnancy-induced hypertension;Gestational diabetes mellitus;Postpartum hemorrhage;Preterm birth rate (<37 gestational weeks at delivery);Neonatal birth weight;Incidence of Low Birth Weight Infants;Incidence of Small for Gestational Age (SGA);Macrosomia incidence;Large-for-gestational-age (LGA) incidence;NICU admission rate;Incidence of congenital anomalies;Neonatal mortality;

Countries

China

Contacts

Public ContactSun Zhen-Gao

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

sunzhengao77@126.com13708938621

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026