Infertility, FemalePhase 3NCT04935073
Traditional Chinese Medicine Herbs in the Freeze-all IVF Cycle
A Phase 3 study testing Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu Tang and Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection in people with Infertility, Female, run by Peking University Third Hospital.
Trial summary
In the early stage, the preliminary study found that traditional Chinese medicine (TCM) intervention aimed at Nourishing kidney and regulating blood circulation in freeze-all IVF cycles can improve the clinical pregnancy rate. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu Tang and Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2021to 30 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Meet the diagnostic criteria for infertility.
- Meet the criteria for identifying kidney deficiency in TCM.
- Patients who Planning to undergo IVF-ET for pregnancy in our center, Age ≤40 years and ≥25 years.
- Previous embryo transfer failure ≥ 2 times.
- Menstrual cycle is basically normal, and normal ovulation has been monitored in the past.
- There were more than 1 blastocyst /more than 2 high-quality embryos with more than 6 cells on day 3/more than 2 high-quality embryos with more than 4 cells on day 2.
- Consent to participate in this clinical trial and sign an informed consent form.
Who cannot join
- Patients with endometritis, acute pelvic inflammatory disease, mycotic vaginitis, bacterial vaginitis, adnexitis or other systemic infections.
- It has been confirmed that there are obvious and serious other organic lesions in the reproductive organs.
- Patients with allergic constitution
- Infertility caused by genetic factors
- Patients with serious primary diseases such as cardio cerebrovascular, kidney, liver and hematopoietic system and psychosis
- A person who is unable to cooperate (such as a combination of neurological or mental illness, or a reluctance to cooperate)
- The endometrial thickness on the day of hCG was less than 6 mm or the endometrial morphology on the day of hCG was type C
- Those who did not agree to participate in the study
Trial locations and contacts
No sites are listed yet.
Ruiwen Fan contact
About this study
Official title: A Randomized Controlled Study on the Short-term Intervention of Traditional Chinese Medicine Herbs in the Freeze-all IVF Cycle to Improve Pregnancy Rate
In the early stage, the preliminary study found that traditional Chinese medicine (TCM) intervention aimed at Nourishing kidney and regulating blood circulation in freeze-all IVF cycles can improve the clinical pregnancy rate. In order to further study the role of TCM in improving the pregnancy outcome of IVF-ET in infertility. A randomized controlled clinical trial will be used in this study. 90 infertile patients are randomly divided into two groups. The control group will be treated with conventional modern medicine, and the treatment group will be treated with traditional Chinese herbs on the basis of conventional modern medicine. The intervention starts from the 5th day of the menstrual cycle and lasts until the day before IVF-ET. After the transplantation, the TCM treatment continues for 14 days. The number of oocytes, antral follicles, AMH, serum FSH, and clinical pregnancy rate will be observed to evaluate the effect of TCM herbs on the improvement of pregnancy outcomes. In addition, all the participants will be asked to complete the self-evaluation of the anxiety/depression scale on the 7th day of the menstrual cycle, before and after transplantation, to analyze the emotional changes of the subjects during the study. The study will also observe the safety and health economic indicators of TCM treatment, so as to improve the overall efficacy of TCM Combined Application in assisted reproductive technology in the future.
Read the detailed description
The trial is designed as a randomized, controlled clinical trial with two groups established by 1:1 equal allocation, a treatment group with interventions using herbs to tonify the kidneys and regulate blood and a control group treated using conventional Western medicine. Random numbers will be prepared by an independent third-party statistician who prepared a list of random group codes for this study. Enrolled subjects will be given a subject number during the screening process and, upon formal enrolment, will be randomly assigned to either the test or control group with a corresponding random number.
Interventions Treatment method Phase 1: The control group will be treated with conventional Western medicine, whereas the treatment group will receive treatment with the Chinese herbal formula. Treatment with the Chinese herbal formula will start on the 5th day of menstruation cycle. The medicines used will be Er Zhi Wan combined with Si Wu Tang (Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 15 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 10 g, Ligusticum wallichii 6 g, Poria cocos 15g,Polygonatum 15g,eclipta 10g); which will be taken for 10-15days.
Phase 2: After ET, the control group will be treated conventionally with no TCM intervention, and the treatment group will continue to take Chinese herbal medicine, changing to Shou Tai pills ( Morinda officinalis 15 g, Teasel 15g，Cuscutae 20 g, Eucommia ulmoides 15 g, Rehmannia 15 g, Cornus officinalis 15 g, loranthus parasiticus 20 g, Ligustrum lucidum 15g, Salvia miltiorrhiza 10g, Scutellaria baicalensis 10g, Atractylodes macrocephala 15g); which will be taken for 14days. The hospital will be responsible for the decoction of 200 mL per dose, 1 dose per day, divided into 2 doses in the morning and in the evening.
Serum human chorionic gonadotropin (hCG) will be measured, and an hCG>30 IU will be considered to indicate biochemical pregnancy. Ultrasound monitoring will be performed 30 days after ET to calculate the clinical pregnancy rate.
- Conditions
- Infertility, Female
- Being tested
- Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu Tang, Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection
- Keywords
- infertility, traditional chinese medicine, freeze-all IVF cycle, Embryo Transfer
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu TangDrug
Also called conventional western medicine(Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection )
The medicines used in this study including Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 15 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 10 g, Ligusticum wallichii 6 g, Poria cocos 15g, Polygonatum 15g, eclipta 10g. which will be taken for 10-15days.After the ET, the treatment group will continue to take Chinese herbal medicine, changing to Shou Tai pills ( Morinda officinalis 15 g, Teasel 15g，Cuscutae 20 g, Eucommia ulmoides 15 g, Rehmannia 15 g, Cornus officinalis 15 g, loranthus parasiticus 20 g, Ligustrum lucidum 15g, Salvia miltiorrhiza 10g, Scutellaria baicalensis 10g, Atractylodes macrocephala 15g); which will be taken for 14days. The hospital will be responsible for the decoction of 200 mL per dose, 1 dose per day, divided into 2 doses in the morning and in the evening.
Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for InjectionDrug
The intervention starts from the 5th day of the menstrual cycle and lasts to the day before IVF-ET.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine herbs treatment group | Experimental | the treatment group will receive treatment with the Chinese herbal formula on the 5th day of the menstrual cycle and lasts to 14 days after IVF-ET. Receives: Drug: Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu Tang; Drug: Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection |
| Western medicine group | Active comparator | The control group will be treated with conventional Western medicine Receives: Drug: Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate (%)
Follow up by telephone calls 14days after the IVF-ET
Measured: up to 6 weeks from enrollment
Secondary outcomes (1)
Concentration of β-human Choriogonadotropin(β-HCG)
Obtained by blood sampling 14days after the proposed IVF-ET
Measured: up to 6 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start15 Jun 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935073
- Sponsor's protocol ID
- IRB00006761-M2020442
- Status last verified
- Jun 2021
- First submitted
- 13 May 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Short-term Intervention of Traditional Chinese Medicine Herbs in the Freeze-all IVF Cycle to Improve Pregnancy Rate
- ClinicalTrials.gov ID
- NCT04935073
- Acronym / sponsor ID
- IRB00006761-M2020442
- Conditions
- Infertility, Female
- Keywords
- infertility, traditional chinese medicine, freeze-all IVF cycle, Embryo Transfer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Jun 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the early stage, the preliminary study found that traditional Chinese medicine (TCM) intervention aimed at Nourishing kidney and regulating blood circulation in freeze-all IVF cycles can improve the clinical pregnancy rate. In order to further study the role of TCM in improving the pregnancy outcome of IVF-ET in infertility. A randomized controlled clinical trial will be used in this study. 90 infertile patients are randomly divided into two groups. The control group will be treated with conventional modern medicine, and the treatment group will be treated with traditional Chinese herbs on the basis of conventional modern medicine. The intervention starts from the 5th day of the menstrual cycle and lasts until the day before IVF-ET. After the transplantation, the TCM treatment continues for 14 days. The number of oocytes, antral follicles, AMH, serum FSH, and clinical pregnancy rate will be observed to evaluate the effect of TCM herbs on the improvement of pregnancy outcomes. In addition, all the participants will be asked to complete the self-evaluation of the anxiety/depression scale on the 7th day of the menstrual cycle, before and after transplantation, to analyze the emotional changes of the subjects during the study. The study will also observe the safety and health economic indicators of TCM treatment, so as to improve the overall efficacy of TCM Combined Application in assisted reproductive technology in the future.
Detailed description
The trial is designed as a randomized, controlled clinical trial with two groups established by 1:1 equal allocation, a treatment group with interventions using herbs to tonify the kidneys and regulate blood and a control group treated using conventional Western medicine. Random numbers will be prepared by an independent third-party statistician who prepared a list of random group codes for this study. Enrolled subjects will be given a subject number during the screening process and, upon formal enrolment, will be randomly assigned to either the test or control group with a corresponding random number.
Interventions Treatment method Phase 1: The control group will be treated with conventional Western medicine, whereas the treatment group will receive treatment with the Chinese herbal formula. Treatment with the Chinese herbal formula will start on the 5th day of menstruation cycle. The medicines used will be Er Zhi Wan combined with Si Wu Tang (Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 15 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 10 g, Ligusticum wallichii 6 g, Poria cocos 15g,Polygonatum 15g,eclipta 10g); which will be taken for 10-15days.
Phase 2: After ET, the control group will be treated conventionally with no TCM intervention, and the treatment group will continue to take Chinese herbal medicine, changing to Shou Tai pills ( Morinda officinalis 15 g, Teasel 15g，Cuscutae 20 g, Eucommia ulmoides 15 g, Rehmannia 15 g, Cornus officinalis 15 g, loranthus parasiticus 20 g, Ligustrum lucidum 15g, Salvia miltiorrhiza 10g, Scutellaria baicalensis 10g, Atractylodes macrocephala 15g); which will be taken for 14days. The hospital will be responsible for the decoction of 200 mL per dose, 1 dose per day, divided into 2 doses in the morning and in the evening.
Serum human chorionic gonadotropin (hCG) will be measured, and an hCG>30 IU will be considered to indicate biochemical pregnancy. Ultrasound monitoring will be performed 30 days after ET to calculate the clinical pregnancy rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine herbs treatment group | Experimental | Drug: Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu Tang, Drug: Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injectionthe treatment group will receive treatment with the Chinese herbal formula on the 5th day of the menstrual cycle and lasts to 14 days after IVF-ET. |
| Western medicine group | Active comparator | Drug: Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for InjectionThe control group will be treated with conventional Western medicine |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Meet the diagnostic criteria for infertility.
- Meet the criteria for identifying kidney deficiency in TCM.
- Patients who Planning to undergo IVF-ET for pregnancy in our center, Age ≤40 years and ≥25 years.
- Previous embryo transfer failure ≥ 2 times.
- Menstrual cycle is basically normal, and normal ovulation has been monitored in the past.
Key exclusion criteria (8 listed)
- Patients with endometritis, acute pelvic inflammatory disease, mycotic vaginitis, bacterial vaginitis, adnexitis or other systemic infections.
- It has been confirmed that there are obvious and serious other organic lesions in the reproductive organs.
- Patients with allergic constitution
- Infertility caused by genetic factors
- Patients with serious primary diseases such as cardio cerebrovascular, kidney, liver and hematopoietic system and psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu TangAlso: conventional western medicine(Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection )The medicines used in this study including Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 15 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 10 g, Ligusticum wallichii 6 g, Poria cocos 15g, Polygonatum 15g, eclipta 10g. which will be taken for 10-15days.After the ET, the treatment group will continue to take Chinese herbal medicine, changing to Shou Tai pills ( Morinda officinalis 15 g, Teasel 15g，Cuscutae 20 g, Eucommia ulmoides 15 g, Rehmannia 15 g, Cornus officinalis 15 g, loranthus parasiticus 20 g, Ligustrum lucidum 15g, Salvia miltiorrhiza 10g, Scutellaria baicalensis 10g, Atractylodes macrocephala 15g); which will be taken for 14days. The hospital will be responsible for the decoction of 200 mL per dose, 1 dose per day, divided into 2 doses in the morning and in the evening. | Drug | Traditional Chinese Medicine herbs treatment group |
| Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for InjectionThe intervention starts from the 5th day of the menstrual cycle and lasts to the day before IVF-ET. | Drug | Traditional Chinese Medicine herbs treatment group, Western medicine group |
Primary outcome
Clinical pregnancy rate (%)
Time frame: up to 6 weeks from enrollment
Follow up by telephone calls 14days after the IVF-ET
1 secondary outcome
Concentration of β-human Choriogonadotropin(β-HCG)
Time frame: up to 6 weeks from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruiwen Fan contact
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu Tang and Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection in people with Infertility, Female, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiyan Xin (+86 0108226-4621, xinxiyan198234@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (%) (time frame: up to 6 weeks from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.