N/A
N=1,467
The Application of Zishen Yutai Pill in Aged Women Undergoing IVF-ET
Infertility, Female
Bottom Line
View on ClinicalTrials.gov: NCT03703700 ↗Enrolled (actual)
1,467
Serious AEs
2.7%
Results posted
Mar 2025
Primary outcome: Primary: Live Birth Rate — 171; 139 Participants — p=0.042
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zishen Yutai Pill (Drug); Placebo (Drug)
- Age
- Adult · 35+ yrs
- Sex
- Female
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Live Birth Rate |
171; 139 | 0.042 sig |
| SECONDARY Number of Retrieved Oocytes |
9; 9 | 0.781 |
| SECONDARY Rate of Retrieved Oocytes |
85.7; 88.9 | 0.609 |
| SECONDARY Number of Matured Oocytes Retrieved |
8; 7 | 0.528 |
| SECONDARY Rate of Matured Oocytes |
90.0; 90.9 | 0.880 |
| SECONDARY Number of Cleavage |
7; 6 | 0.289 |
| SECONDARY Cleavage Rate |
91.0; 90.0 | 0.860 |
| SECONDARY Number of Available Embryos |
4; 3 | 0.163 |
| SECONDARY Rate of Available Embryos |
57.1; 50.0 | 0.197 |
| SECONDARY Number of High-quality Embryos |
2; 2 | 0.178 |
| SECONDARY Rate of High-quality Embryos |
50.0; 50.0 | 0.549 |
| SECONDARY Biochemical Pregnancy Rate |
232; 195 | 0.035 sig |
| SECONDARY Implantation Rate |
252; 204 | 0.034 sig |
| SECONDARY Clinical Pregnancy Rate |
216; 177 | 0.022 sig |
| SECONDARY Miscarriage Rate (Among Positive Pregnancy Test Population) |
57; 51 | 0.707 |
| SECONDARY Miscarriage Rate (Among Clinical Pregnancy Population) |
45; 38 | 0.878 |
| SECONDARY The Birth Weight of the Newborn |
3250.0; 3260.0; 2450.0; 2275.0 | 0.564 |
| SECONDARY The Birth Height of the Newborn |
50.0; 50.0; 48.0; 48.0 | 0.985 |
| SECONDARY Preterm Delivery Among Live Birth |
29; 22 | 0.789 |
| SECONDARY Low Birth Weight Among Neonates |
24; 18 | 0.769 |
| SECONDARY Congenital Anomalies Among Neonates |
1; 2 | 0.590 |
| SECONDARY Neonates Entering NICU |
5; 2 | 0.465 |
Summary
To explore the application of Zishen Yutai Pill in controlled ovarian stimulation and effect on pregnancy outcome in aged women undergoing in vitro fertilization-embryo transfer.
Eligibility Criteria
Inclusion Criteria
- infertile women aged ≥35 and ≤42 years;
- intend to undergo IVF/ICSI-ET (GnRH-a long protocol or GnRH-ant protocol);
- BMI<28kg/m2;
- bilateral ovaries exist;
- patients who voluntarily signed the informed consent and agreed to be followed up as required by the study protocol.
Exclusion Criteria
- repeated implantation failure (previous three times or more IVF/ICSI-ET failure);
- adenomyosis, uterine line constricted by uterine fibroid;
- untreated bilateral hydrosalpinx;
- endometrial diseases that have not been cured ;
- known diseases that are not suitable for undergoing assisted reproductive technology or at the present not suitable for pregnancy;
- patients who have taken traditional Chinese medicine or Chinese patent medicine for infertility treatment in the last month(30 days).
Exit Criteria:
- subjects who have adverse events cannot be tolerated;
- severe breach of the protocol;
- for subjects who exit due to personal or unpredictable reasons, please describe specific details;
- subjects considered inappropriate to continue to participate in the study for other medical reasons.
Data sourced from ClinicalTrials.gov (NCT03703700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.