EndometriosisPhase 2NCT02676713
Traditional Chinese Medicine Sequential Treatment for Endometriosis Associated Infertility
A Phase 2 study testing pre-ovulation Decoction and post-ovulation Decoction in people with Endometriosis and Infertility, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 6 sites in China.
Trial summary
Endometriosis is a common, chronic disease. 30% to 50% of women with endometriosis are infertile. There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis increases live birth or ongoing pregnancy rates. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Endometriosis, Infertility
- What is being tested?
- pre-ovulation Decoction and post-ovulation Decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 6 sitesChina
- Study dates
- Dec 2014to Dec 2017
- Phase
- Phase 2
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of endometriosis, infertility, with Syndrome of qi stagnation blood stasis pattern in TCM ;
- The first time undergoing Laparoscopic or laparoscopy combined surgery , in lined with endometriosis-related infertility, tubal patency or obstruction lightly;
- EFI score greater than 4 points;
- Early follicular phase FSH≤10mIU / L;
- 28 days of the menstrual cycle ± 7 days;
- Female patients between 20-35 years old;
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- No previous history of severe drug allergies;
- Past Three-month no taking hormone drugs such as danazol, Gestrinone, GnRHa;
- No severe primary brain vascular diseases, liver, kidney and hematopoietic systems diseases, no history of mental illness, no drugs, alcohol, tobacco, caffeine dependent history;
- Have signed informed consent
Who cannot join
- Associated with uterine fibroids, the diameter greater than 4cm, adenomyosis, pelvic tuberculosis, endometrial tuberculosis, intrauterine adhesions, polycystic ovary syndrome, hyperprolactinemia, thyroid dysfunction patients.
- Serious history of drug allergy.
- Male factor infertility.
- The couple separated persons.
Trial locations and contacts
6 sites in 1 country.
Jie Wang, Doctor contact
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing Obstetrics and Gynecology Hospital,Captial Medical University
Beijing, Beijing Municipality, 100026
Dan Lu, PHD, 8601052276423
- Recruiting
GAMHospital
Beijing, Beijing Municipality, 100053
Yi Tang, MD, 13260185007, yier1990@126.com
Yong Liu, 13488676266, liuyong115@126.com
- Recruiting
Beijng Hospital
Beijng, 100730
Qingwei Meng, PHD, 8601085138118
- Recruiting
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong, 510405
Cheng Zeng, PHD, 8602036591369
- Recruiting
Traditional Chinese Medicine Hospital of Guangdong Province
Guangzhou, Guangdong
Xiaoyun Wang, PHD, 8602081887233
- Recruiting
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui, 230031
Weili Li, PHD, 8601052276423
About this study
Official title: Activating Blood, Dredging Liver and Nourishing Kidney Sequential Treatment for Endometriosis Associated Infertility - a Randomized Double-blind Placebo Controlled Study
Endometriosis is a common, chronic disease. 30% to 50% of women with endometriosis are infertile. There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis increases live birth or ongoing pregnancy rates. There was no evidence of benefit for post-surgical hormonal suppression of endometriosis compared to surgery alone for the outcomes of pregnancy rates. Past studies have confirmed that Chinese herbal medicine can inhibit post-surgical endometriosis recurrence, increase pregnancy rate.This study evaluates the efficacy and safety of Traditional Chinese Medicine Sequential Treatment of endometriosis-associated infertility. The study objective is to confirm that clinical pregnancy rate of patients with endometriosis-associated infertility post-conservative surgery accepting Chinese medicine activating blood, dredging liver and nourishing kidney sequential treatment is higher than expectant treatment.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, multicenter, prospective clinical study, conducted in China (six research centers).
204 cases of patients with endometriosis-associated infertility confined with Syndrome of qi stagnation blood stasis pattern in TCM after conservative surgery will be recruited. Patients will be randomly divided into two groups: experimental group (TCM Sequential Treatment) and control group (placebo). All the patients are treated for six menstrual cycles, taking pre-ovulation decoction before ovulation and post-ovulation decoction after ovulation. Pre-ovulation decoction of experimental group is HuoXueXiaoYi decoction, and post-ovulation decoction is BuShenZhuYun decoction. The drug of control group is placebo.
Each menstrual cycle, patient is monitored of antral follicle count (AFC), ovulation, endometrial thickness, and endometrial blood flow by ultrasonography, and need fill TCM syndrome rating scale, pictorial blood loss assessment chart (PBAC), and the visual analogue scale(VAS).The 1st, 3rd, 6th menstrual cycle after surgery, the level of serum female hormone (FSH, LH, E2) are detected in menstrual period of 2 to 5 days, and female hormone (E2, P) in the middle of the corpus luteum 6-9 days.
Patient must be security check (blood routine, urine routine, liver and kidney function, electrocardiogram) before and after drug treatment. Such as patients find pregnancy during medication, adopt the security check in finding pregnancy 7 days.
Patients after amenorrhea need to be confirmed pregnancy by serum β-HCG detection. According to the level of serum HCG, E2 and P and clinical symptoms, corresponding tocolytic treatment will be given. At 6～8 weeks of pregnancy, patient need to be confirmed the clinical pregnancy by ultrasonography. If confirmed the clinical pregnancy (at least having one heart throb in intrauterine gestational sac), patient need to be confirmed ongoing pregnancy by ultrasonography at the 12～14 weeks of pregnancy.
In the process of the entire study, adverse events will be closely observed, and the frequency and severity of adverse events will be recorded.
- Conditions
- Endometriosis, Infertility
- Being tested
- pre-ovulation Decoction, post-ovulation Decoction, pre-ovulation Decoction(placebo), post-ovulation Decoction(placebo)
- Keywords
- Traditional Chinese Medicine, Chinese Herbal
- Medical subject headings
- Endometriosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-ovulation DecoctionDrug
Also called HuoXueXiaoYi Decoction
HuoXueXiaoYi Decoction(Bupleurum 10g, Cyperus 10g, Salvia miltiorrhiza 20g, Red peony 10g,etc)has activating blood and absorbing clots effect, can inhibit the growth of ectopic endometrium, promote follicular growth, maturity, improve ovulation and the receptivity of endometrium.
post-ovulation DecoctionDrug
Also called BuShenZhuYun Decoction
BuShenZhuYun Decoction(Bupleurum 10g,Poria 15g, Atractylodes 15g,Ligustrum 15g,etc) has dredging liver and nourishing kidney effect, can improve the function of corpus luteum.
All are made into granules.
pre-ovulation Decoction(placebo)Drug
Also called placebo
Composition of maltodextrin, lactose, edible pigment, taste masking agent.
post-ovulation Decoction(placebo)Drug
Also called placebo
Composition of maltodextrin, lactose, edible pigment, taste masking agent.
| Study group | Role | What they receive |
|---|---|---|
| TCM Sequential Treatment | Experimental | After conservative surgery, patients start to take pre-ovulation decoction for 14 days. Each menstrual period 2～5 days, patients start to take pre-ovulation decoction. If ultrasonography found ovulation, change to take post-ovulation decoction. If having taken 14 days, ultrasonography found LUFS or no follicle develop maturity, change to take post-ovulation decoction. Taking post-ovulation decoction for 14 days, or continue to next time menstruation. Taking medication for six menstrual cycles.
Pre-ovulation decoction is HuoXueXiaoYi decoction, and post-ovulation decoction is BuShenZhuYun decoction. 2 bags each time, 2 times a day, fused with hot water, 1 hour after dinner.
All drugs are tcm formula granules, manufactured by Jiangyin Tianjiang Pharmaceutical Co. ltd Receives: Drug: pre-ovulation Decoction; Drug: post-ovulation Decoction |
| Placebo | Placebo comparator | After conservative surgery, patients start to take pre-ovulation decoction(placebo) for 14 days. Each menstrual period 2～5 days, patients start to take pre-ovulation decoction. If ultrasonography found ovulation, change to take post-ovulation decoction. If having taken 14 days, ultrasonography found luteinized unruptured follicle syndrome (LUFS) or no follicle develop maturity, change to take post-ovulation decoction. Taking post-ovulation decoction(placebo) for 14 days, or continue to next time menstruation. Taking medication for six menstrual cycles. 2 bags each time, 2 times a day, fused with hot water, 1 hour after dinner.
Pre-ovulation decoction and post-ovulation decoction is placebo, manufactured by Jiangyin Tianjiang Pharmaceutical Co. ltd Receives: Drug: pre-ovulation Decoction(placebo); Drug: post-ovulation Decoction(placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Pregnancy rate is defined as the proportion of participants finding pregnancy after amenorrhea and confirming serumβ-HCG positive.
Measured: six menstrual cycles（each cycle is 28±7 days）
Secondary outcomes (3)
Clinical pregnancy rate (with intrauterine pregnancy sac)
defined as the proportion of participants confirmed there are at least one gestational sac in uterine cavity (No matter whether there is a heart throb) by ultrasonography.
Measured: at 6～8 weeks of pregnancy
Clinical pregnancy rate (with a heart throb)
defined as the proportion of participants confirmed at least having one heart throb in intrauterine gestational sac by ultrasonography.
Measured: at 6～8 weeks of pregnancy
Continued pregnancy rate
defined as the proportion of participants confirmed at least one live fetuses by ultrasonography.
Measured: at the 12～14 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startDec 2014
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Beijing Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Zhao RuiHua, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Ruihua Zhao, Doctor, Study chair, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676713
- Sponsor's protocol ID
- GAMHospital
- Other IDs
- 2014BAI10B08
- Status last verified
- Feb 2016
- First submitted
- 16 Aug 2015
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Duffy JM, Arambage K, Correa FJ, Olive D, Farquhar C, Garry R, Barlow DH, Jacobson TZ. Laparoscopic surgery for endometriosis. Cochrane Database Syst Rev. 2014 Apr 3;(4):CD011031. doi: 10.1002/14651858.CD011031.pub2.
PubMed 24696265Yap C, Furness S, Farquhar C. Pre and post operative medical therapy for endometriosis surgery. Cochrane Database Syst Rev. 2004;2004(3):CD003678. doi: 10.1002/14651858.CD003678.pub2.
PubMed 15266496Zhao RH, Hao ZP, Zhang Y, Lian FM, Sun WW, Liu Y, Wang R, Long L, Cheng L, Ding YF, Song DR, Meng QW, Wang AM. Controlling the recurrence of pelvic endometriosis after a conservative operation: comparison between Chinese herbal medicine and western medicine. Chin J Integr Med. 2013 Nov;19(11):820-5. doi: 10.1007/s11655-012-1247-z. Epub 2012 Dec 22.
PubMed 23292545Zhao RH, Liu Y, Lu D, Wu Y, Wang XY, Li WL, Zeng C, Meng QW, Lian FM, Zhou J, Shi Y, Sun WW, Han Q, Tang Y, Shi G. Chinese Medicine Sequential Therapy Improves Pregnancy Outcomes after Surgery for Endometriosis-Associated Infertility: A Multicenter Randomized Double-blind Placebo Parallel Controlled Clinical Trial. Chin J Integr Med. 2020 Feb;26(2):92-99. doi: 10.1007/s11655-019-3208-2. Epub 2020 Jan 29.
PubMed 31997236
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Blood, Dredging Liver and Nourishing Kidney Sequential Treatment for Endometriosis Associated Infertility - a Randomized Double-blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02676713
- Acronym / sponsor ID
- GAMHospital
- Conditions
- Endometriosis, Infertility
- Keywords
- Traditional Chinese Medicine, Chinese Herbal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, Beijing Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Study start
- Dec 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Feb 2016 (estimated)
- 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.
Endometriosis is a common, chronic disease. 30% to 50% of women with endometriosis are infertile. There is moderate quality evidence that laparoscopic surgery to treat mild and moderate endometriosis increases live birth or ongoing pregnancy rates. There was no evidence of benefit for post-surgical hormonal suppression of endometriosis compared to surgery alone for the outcomes of pregnancy rates. Past studies have confirmed that Chinese herbal medicine can inhibit post-surgical endometriosis recurrence, increase pregnancy rate.This study evaluates the efficacy and safety of Traditional Chinese Medicine Sequential Treatment of endometriosis-associated infertility. The study objective is to confirm that clinical pregnancy rate of patients with endometriosis-associated infertility post-conservative surgery accepting Chinese medicine activating blood, dredging liver and nourishing kidney sequential treatment is higher than expectant treatment.
Detailed description
This study is a randomized, double-blind, placebo-controlled, multicenter, prospective clinical study, conducted in China (six research centers).
204 cases of patients with endometriosis-associated infertility confined with Syndrome of qi stagnation blood stasis pattern in TCM after conservative surgery will be recruited. Patients will be randomly divided into two groups: experimental group (TCM Sequential Treatment) and control group (placebo). All the patients are treated for six menstrual cycles, taking pre-ovulation decoction before ovulation and post-ovulation decoction after ovulation. Pre-ovulation decoction of experimental group is HuoXueXiaoYi decoction, and post-ovulation decoction is BuShenZhuYun decoction. The drug of control group is placebo.
Each menstrual cycle, patient is monitored of antral follicle count (AFC), ovulation, endometrial thickness, and endometrial blood flow by ultrasonography, and need fill TCM syndrome rating scale, pictorial blood loss assessment chart (PBAC), and the visual analogue scale(VAS).The 1st, 3rd, 6th menstrual cycle after surgery, the level of serum female hormone (FSH, LH, E2) are detected in menstrual period of 2 to 5 days, and female hormone (E2, P) in the middle of the corpus luteum 6-9 days.
Patient must be security check (blood routine, urine routine, liver and kidney function, electrocardiogram) before and after drug treatment. Such as patients find pregnancy during medication, adopt the security check in finding pregnancy 7 days.
Patients after amenorrhea need to be confirmed pregnancy by serum β-HCG detection. According to the level of serum HCG, E2 and P and clinical symptoms, corresponding tocolytic treatment will be given. At 6～8 weeks of pregnancy, patient need to be confirmed the clinical pregnancy by ultrasonography. If confirmed the clinical pregnancy (at least having one heart throb in intrauterine gestational sac), patient need to be confirmed ongoing pregnancy by ultrasonography at the 12～14 weeks of pregnancy.
In the process of the entire study, adverse events will be closely observed, and the frequency and severity of adverse events will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM Sequential Treatment | Experimental | Drug: pre-ovulation Decoction, Drug: post-ovulation DecoctionAfter conservative surgery, patients start to take pre-ovulation decoction for 14 days. Each menstrual period 2～5 days, patients start to take pre-ovulation decoction. If ultrasonography found ovulation, change to take post-ovulation decoction. If having taken 14 days, ultrasonography found LUFS or no follicle develop maturity, change to take post-ovulation decoction. Taking post-ovulation decoction for 14 days, or continue to next time menstruation. Taking medication for six menstrual cycles. Pre-ovulation decoction is HuoXueXiaoYi decoction, and post-ovulation decoction is BuShenZhuYun decoction. 2 bags each time, 2 times a day, fused with hot water, 1 hour after dinner. All drugs are tcm formula granules, manufactured by Jiangyin Tianjiang Pharmaceutical Co. ltd |
| Placebo | Placebo comparator | Drug: pre-ovulation Decoction(placebo), Drug: post-ovulation Decoction(placebo)After conservative surgery, patients start to take pre-ovulation decoction(placebo) for 14 days. Each menstrual period 2～5 days, patients start to take pre-ovulation decoction. If ultrasonography found ovulation, change to take post-ovulation decoction. If having taken 14 days, ultrasonography found luteinized unruptured follicle syndrome (LUFS) or no follicle develop maturity, change to take post-ovulation decoction. Taking post-ovulation decoction(placebo) for 14 days, or continue to next time menstruation. Taking medication for six menstrual cycles. 2 bags each time, 2 times a day, fused with hot water, 1 hour after dinner. Pre-ovulation decoction and post-ovulation decoction is placebo, manufactured by Jiangyin Tianjiang Pharmaceutical Co. ltd |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Clinical diagnosis of endometriosis, infertility, with Syndrome of qi stagnation blood stasis pattern in TCM ;
- The first time undergoing Laparoscopic or laparoscopy combined surgery , in lined with endometriosis-related infertility, tubal patency or obstruction lightly;
- EFI score greater than 4 points;
- Early follicular phase FSH≤10mIU / L;
- 28 days of the menstrual cycle ± 7 days;
Key exclusion criteria (4 listed)
- Associated with uterine fibroids, the diameter greater than 4cm, adenomyosis, pelvic tuberculosis, endometrial tuberculosis, intrauterine adhesions, polycystic ovary syndrome, hyperprolactinemia, thyroid dysfunction patients.
- Serious history of drug allergy.
- Male factor infertility.
- The couple separated persons.
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 |
|---|---|---|
| pre-ovulation DecoctionAlso: HuoXueXiaoYi DecoctionHuoXueXiaoYi Decoction(Bupleurum 10g, Cyperus 10g, Salvia miltiorrhiza 20g, Red peony 10g,etc)has activating blood and absorbing clots effect, can inhibit the growth of ectopic endometrium, promote follicular growth, maturity, improve ovulation and the receptivity of endometrium. | Drug | TCM Sequential Treatment |
| post-ovulation DecoctionAlso: BuShenZhuYun DecoctionBuShenZhuYun Decoction(Bupleurum 10g,Poria 15g, Atractylodes 15g,Ligustrum 15g,etc) has dredging liver and nourishing kidney effect, can improve the function of corpus luteum. All are made into granules. | Drug | TCM Sequential Treatment |
| pre-ovulation Decoction(placebo)Also: placeboComposition of maltodextrin, lactose, edible pigment, taste masking agent. | Drug | Placebo |
| post-ovulation Decoction(placebo)Also: placeboComposition of maltodextrin, lactose, edible pigment, taste masking agent. | Drug | Placebo |
Primary outcome
Pregnancy rate
Time frame: six menstrual cycles（each cycle is 28±7 days）
Pregnancy rate is defined as the proportion of participants finding pregnancy after amenorrhea and confirming serumβ-HCG positive.
3 secondary outcomes
Clinical pregnancy rate (with intrauterine pregnancy sac)
Time frame: at 6～8 weeks of pregnancy
Clinical pregnancy rate (with a heart throb)
Time frame: at 6～8 weeks of pregnancy
Continued pregnancy rate
Time frame: at the 12～14 weeks of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Background: PubMed 24696265Duffy JM, Arambage K, Correa FJ, Olive D, Farquhar C, Garry R, Barlow DH, Jacobson TZ. Laparoscopic surgery for endometriosis. Cochrane Database Syst Rev. 2014 Apr 3;(4):CD011031. doi: 10.1002/14651858.CD011031.pub2.
- Background: PubMed 15266496Yap C, Furness S, Farquhar C. Pre and post operative medical therapy for endometriosis surgery. Cochrane Database Syst Rev. 2004;2004(3):CD003678. doi: 10.1002/14651858.CD003678.pub2.
- Results publication: PubMed 23292545Zhao RH, Hao ZP, Zhang Y, Lian FM, Sun WW, Liu Y, Wang R, Long L, Cheng L, Ding YF, Song DR, Meng QW, Wang AM. Controlling the recurrence of pelvic endometriosis after a conservative operation: comparison between Chinese herbal medicine and western medicine. Chin J Integr Med. 2013 Nov;19(11):820-5. doi: 10.1007/s11655-012-1247-z. Epub 2012 Dec 22.
- Derived from this study: PubMed 31997236Zhao RH, Liu Y, Lu D, Wu Y, Wang XY, Li WL, Zeng C, Meng QW, Lian FM, Zhou J, Shi Y, Sun WW, Han Q, Tang Y, Shi G. Chinese Medicine Sequential Therapy Improves Pregnancy Outcomes after Surgery for Endometriosis-Associated Infertility: A Multicenter Randomized Double-blind Placebo Parallel Controlled Clinical Trial. Chin J Integr Med. 2020 Feb;26(2):92-99. doi: 10.1007/s11655-019-3208-2. Epub 2020 Jan 29.
- Individual participant dataSharing planned: No
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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.
Jie Wang, Doctor contact
Ruihua Zhao, Doctor study chair
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pre-ovulation Decoction and post-ovulation Decoction in people with Endometriosis and Infertility, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 6 sites in China.
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 10 inclusion and 4 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 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yi Tang, Master (+86 13260185007, yier1990@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: six menstrual cycles（each cycle is 28±7 days）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02676713, which also lists 4 linked publications.
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 19 Feb 2016.