Trial · NCT03703700
The Application of Zishen Yutai Pill in Aged Women Undergoing IVF-ET
NCT03703700, Not applicable, Completed, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; results first posted 2025-03-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Application of Zishen Yutai Pill in Aged Women Undergoing IVF-ET. Trials, record NCT03703700. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03703700
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Application of Zishen Yutai Pill in Aged Women Undergoing IVF-ET
- NCT number
- NCT03703700
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,467 participants, actual
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Conditions
- Infertility, Female
- Interventions
- Zishen Yutai Pill, Placebo
- First posted
- 2018-10-12
- Last updated
- 2025-03-25
- Results first posted
- 2025-03-25
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Live Birth Rate | 1 year after embryo transfer day, up to a maximum duration of 58 weeks | Live birth rate=Number of live birth / Paticipants randomized |
| Secondary | Number of Retrieved Oocytes | On embryo transfer day, approximately 6 weeks | The total number of oocytes retrieved through ultrasound-guided transvaginal aspiration. |
| Secondary | Rate of Retrieved Oocytes | On embryo transfer day, approximately 6 weeks | Rate of retrieved oocytes =Number of retrieved oocytes/Number of follicles with a diameter ≥10mm on the HCG injection day. |
| Secondary | Number of Matured Oocytes Retrieved | On embryo transfer day, approximately 6 weeks | The number of oocytes with pronuclei or polar bodies observed on Day 1 after oocyte retrieval in IVF patients, or as the number of MII oocytes on the day of oocyte retrieval in ICSI patients. |
| Secondary | Rate of Matured Oocytes | On embryo transfer day, approximately 6 weeks | Rate of mature oocytes = Number of mature oocytes/Number of retrieved oocytes |
| Secondary | Number of Cleavage | On embryo transfer day, approximately 6 weeks | Number of fertilized oocytes that undergo cleavage on Day 2 after oocyte retrieval. |
| Secondary | Cleavage Rate | On embryo transfer day, approximately 6 weeks | Cleavage rate=Number of all cleaved embryos/Number of fertilized oocytes (2PN+1PN+ multiple PN) |
| Secondary | Number of Available Embryos | On embryo transfer day, approximately 6 weeks | The sum of the number of embryos transferred and the number of embryos frozen. |
| Secondary | Rate of Available Embryos | On embryo transfer day, approximately 6 weeks | Rate of available embryos=Number of available embryos/Number of cleaved oocytes. |
| Secondary | Number of High-quality Embryos | On embryo transfer day, approximately 6 weeks | High-quality embryo will be defined according to the day of embryo transfer, following the Istanbul consensus and Gardner criteria, Day 2: 4 cells, cell fragments \<10% and no multi-nucleus; Day 3: 8 cells, cell fragments \<10%, no multi-nucleus; Day 5: stage 4 blastocyst, grade A inner cell mass, grade A trophectoderm (12,13). |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Live Birth Rate | 1 year after embryo transfer day, up to a maximum duration of 58 weeks | ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Retrieved Oocytes | On embryo transfer day, approximately 6 weeks | ITT population | oocytes | MEDIAN |
| SECONDARY | Rate of Retrieved Oocytes | On embryo transfer day, approximately 6 weeks | ITT population | percentage of retrieved oocytes | MEDIAN |
| SECONDARY | Number of Matured Oocytes Retrieved | On embryo transfer day, approximately 6 weeks | ITT population | oocytes | MEDIAN |
| SECONDARY | Rate of Matured Oocytes | On embryo transfer day, approximately 6 weeks | ITT population | percentage of matured oocytes | MEDIAN |
| SECONDARY | Number of Cleavage | On embryo transfer day, approximately 6 weeks | ITT population | oocytes | MEDIAN |
| SECONDARY | Cleavage Rate | On embryo transfer day, approximately 6 weeks | ITT population | percentage of cleaved embryos | MEDIAN |
| SECONDARY | Number of Available Embryos | On embryo transfer day, approximately 6 weeks | ITT population | embryos | MEDIAN |
| SECONDARY | Rate of Available Embryos | On embryo transfer day, approximately 6 weeks | ITT population | percentage of available embryos | MEDIAN |
| SECONDARY | Number of High-quality Embryos | On embryo transfer day, approximately 6 weeks | ITT population | embryos | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Live Birth Rate | Zishen Yutai Pill Group | 171 | Participants | ||
| Live Birth Rate | Placebo Group | 139 | Participants | ||
| Number of Retrieved Oocytes | Zishen Yutai Pill Group | 9 | Inter-Quartile Range 5 to 13 | oocytes | |
| Number of Retrieved Oocytes | Placebo Group | 9 | Inter-Quartile Range 6 to 13 | oocytes | |
| Rate of Retrieved Oocytes | Zishen Yutai Pill Group | 85.7 | Inter-Quartile Range 68.3 to 109.1 | percentage of retrieved oocytes | |
| Rate of Retrieved Oocytes | Placebo Group | 88.9 | Inter-Quartile Range 69.2 to 107.9 | percentage of retrieved oocytes | |
| Number of Matured Oocytes Retrieved | Zishen Yutai Pill Group | 8 | Inter-Quartile Range 5 to 11 | oocytes | |
| Number of Matured Oocytes Retrieved | Placebo Group | 7 | Inter-Quartile Range 4 to 11 | oocytes | |
| Rate of Matured Oocytes | Zishen Yutai Pill Group | 90.0 | Inter-Quartile Range 77.8 to 100.0 | percentage of matured oocytes | |
| Rate of Matured Oocytes | Placebo Group | 90.9 | Inter-Quartile Range 77.7 to 100.0 | percentage of matured oocytes |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zishen Yutai Pill Group | 734 | |
| Overall Study | STARTED | Placebo Group | 733 | |
| Overall Study | COMPLETED | Zishen Yutai Pill Group | 419 | |
| Overall Study | COMPLETED | Placebo Group | 409 | |
| Overall Study | NOT COMPLETED | Zishen Yutai Pill Group | 315 | |
| Overall Study | NOT COMPLETED | Placebo Group | 324 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Ovarian hyperstimulation syndrome | Endocrine disorders | Zishen Yutai Pill Group | 4 | 734 | 4 |
| serious | Ovarian hyperstimulation syndrome | Endocrine disorders | Placebo Group | 6 | 733 | 6 |
| serious | Miscarriage | Pregnancy, puerperium and perinatal conditions | Zishen Yutai Pill Group | 12 | 232 | 12 |
| serious | Miscarriage | Pregnancy, puerperium and perinatal conditions | Placebo Group | 7 | 195 | 7 |
| serious | Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Zishen Yutai Pill Group | 4 | 232 | 4 |
| serious | Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Placebo Group | 5 | 195 | 5 |
| serious | Cryptorchidism | Congenital, familial and genetic disorders | Zishen Yutai Pill Group | 1 | 197 | 1 |
| serious | Cryptorchidism | Congenital, familial and genetic disorders | Placebo Group | 0 | 161 | 0 |
| serious | Appendectomy | Surgical and medical procedures | Zishen Yutai Pill Group | 1 | 734 | 1 |
| serious | Appendectomy | Surgical and medical procedures | Placebo Group | 0 | 733 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zishen Yutai Pill Group | 0 | 734 |
| Total, all-cause mortality | Placebo Group | 0 | 733 |
| Total, other adverse events | Zishen Yutai Pill Group | 0 | 734 |
| Total, other adverse events | Placebo Group | 0 | 733 |
| Total, serious adverse events | Zishen Yutai Pill Group | 22 | 734 |
| Total, serious adverse events | Placebo Group | 18 | 733 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41444477 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Zishen Yutai Pill Group vs Placebo Group: Biochemical Pregnancy Rate | Trial comparisons |
| Zishen Yutai Pill Group vs Placebo Group: Miscarriage Rate (Among Clinical Pregnancy Population) | Trial comparisons |
| Zishen Yutai Pill Group vs Placebo Group: Live Birth Rate | Trial comparisons |
| Zishen Yutai Pill Group vs Placebo Group: Preterm Delivery Among Live Birth | Trial comparisons |
| Zishen Yutai Pill Group vs Placebo Group: deaths from any cause | Trial comparisons |
| Zishen Yutai Pill Group vs Placebo Group: Miscarriage Rate (Among Positive Pregnancy Test Population) | Trial comparisons |
| Zishen Yutai Pill Group vs Placebo Group: Clinical Pregnancy Rate | Trial comparisons |
| Zishen Yutai Pill Group vs Placebo Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03703700
GET https://conductscience.org/api/trials/v1/NCT03703700/registered?page=2