Poor Ovarian ResponseNCT03830697
A Trial Study on Acupuncture Treatment of Poor Ovarian Response
A study testing Acupuncture intervention in people with Poor Ovarian Response, run by Shaanxi Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
The trial was completed by Shaanxi Provincial Hospital of Traditional Chinese Medicine and Northwest Women and Children's Hospital. Thirty-five patients with POR who underwent ART (Assisted Reproductive) treatment were observed in each center. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Poor Ovarian Response
- What is being tested?
- Acupuncture intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2021
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- POR compliant diagnostic criteria
- Intracytoplasmic sperm injection, ICSI)。 Indication with IVF or intracytoplasmic sperm injection (ICSI).
- 3.18≤age<40
Who cannot join
- Repeated spontaneous abortion 2 or more patients (including biochemical pregnancy abortion.
- Patients who have failed to undergo repeated implantation (at least 3 transplanted transplants, at least 3-6 high-quality embryos without clinical pregnancy);
- uterine malformation (single uterus, double uterus, double uterus, untreated mediastinal uterus) and other effects affecting uterine cavity disease (adenomyosis, submucosal uterine fibroids, intrauterine adhesions and scar uterus) Patient;
- Patients and their husbands with abnormal karyotypes (excluding chromosomal polymorphisms;
- Untreated patients with hydrosalpinx;
- (6)Patients with contraindications to ART and pregnancy, or those with a clear influence on pregnancy, such as hypertension, clinically symptomatic heart disease, diabetes, liver disease, kidney disease, severe anemia, history of venous thrombosis, History of pulmonary embolism or cerebrovascular events, history of malignant tumors;
- Refusal to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shaanxi Hospital of Traditional Chinese Medicine
Xi'an, Shaanxi, 710003
Tong sheng Su, M.D., 008615929562568, chinasuts@126.com
Tong Sheng Su, M.D.
About this study
Official title: The Trial Was Completed by Shaanxi Provincial Hospital of Traditional Chinese Medicine and Northwest Women and Children's Hospital. Thirty-five Patients With POR Who Underwent ART (Assisted Reproductive) Treatment Were Observed in Each Center. Patients in the Experimental Group Were Given Acupuncture Treatment for 12 Weeks Prior to COH. If the Patient Has a Good COH Timing During Acupuncture Treatment, She Will Enter the COH Cycle at Any Time. Patients in the Control Group Waiting for 12 Weeks Before COH
The trial was completed by Shaanxi Provincial Hospital of Traditional Chinese Medicine and Northwest Women and Children's Hospital. Thirty-five patients with POR who underwent ART (Assisted Reproductive) treatment were observed in each center. Patients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, she will enter the COH cycle at any time. Patients in the control group waited for 12 weeks before COH. In this study, the COH regimen of the two groups of patients was the same, and the appropriate ovulation induction protocol was selected by the investigator according to the B-ultrasound and endocrine conditions of the patient's menstrual day 1-3. At the end of treatment, patients were observed for the number of eggs in the COH cycle, fertilization rate, cleavage rate, available embryo rate, high quality embryo rate, implantation rate, ovarian reserve function assessment, menstrual status and peri-menopausal symptoms.
Read the detailed description
1.Acupuncture intervention
- test group Patients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, he or she will enter the COH cycle at any time. The acupuncture intervention program of the test group is as follows: Acupoint group 1: Baihui(DU20), Zhongwan(RN12), Tianshu (ST25)(bilateral), Guanyuan(RN4), uterus (bilateral)(EX-CA1), Dahe(KI12) (bilateral),Zusanli (ST36)(bilateral), Sanyinjiao(SP6) (bilateral), Taichong (LR3)(both sides) Acupoint group 2: Baihui(DU20),ShenShu(BL23)、ZhongLiao(BL33)、TaiXi(KI3) Operation: The two-point group was used alternately, with the group 1 as the initial treatment. The patient took the appropriate position (point group 1 was taken in the supine position, group 2 was taken in the prone position), and the local skin of the acupoint was routinely disinfected. Baihui, flat thorn 0.5-1.0 inch; Tai Chong, acupuncture 0.5-1.0 inch in the direction of Yongquan; Shenshu, Taixi, straight thorn 0.5-1.0 inch; ZhongLiao(BL33) , inward and downward oblique thorn 2.0-2.5 inch, It is required to puncture the hole in the second hole; the remaining hole is straight 1.0-1.5 inch. All the acupoints are evenly inserted and twisted (the Baihui acupoints only turn around). Each time the needle is kept for 20 minutes, once every other day, 3 times a week for a total of 12 weeks.
- Control group Patients in the control group waited for 12 weeks before COH。
2.Standard IVF/ICSI Process
- COH process(In this study, the COH regimen was the same in both groups, and the investigator chose the antagonist regimen based on the B-ultrasound and endocrine conditions on the 1-3 day of menstruation.) 1)Gn start time: Menstruation Day3 days, B-ultrasound and hormone levels (FSH/LH/E2/P/β-HCG) suggest that the ovary is in a basal state; 2)Gn starting dose: 75~300 IU; 3)Gn dose adjustment: 5 days after administration, according to ovarian response (B-ultrasound and E2 levels) Whole Gn dose, hMG (Hemeiqi) can be added if necessary; 1 ovarian response is monitored every 1~2 days thereafter (B-ultrasound and E2 level), adjust the amount of Gn accordingly。 4)When the antagonist is added: when the dominant follicle is ≥12mm, add antagonist (Eugly) 250ug/d to HCG day (including HCG day); 5)HCG trigger timing and dose: at least 3 follicles ≥ 18mm, given HCG4000~8000IUim.
- Eggs taken 36 hours after intramuscular injection of HCG:
- In vitro fertilization, embryo culture:In vitro fertilization was performed 4 to 6 hours after egg retrieval, and Day 3 embryos were scored according to the general standards of each center.The two embryos with the highest score were labeled as the embryos of the first embryo transfer. The remaining embryos are often Freeze on Day3, Day5 or Day6.
- Embryo transfer and corpus luteum support:On Day 3, the patient maintained bladder filling and transplanted 2 of the best quality under the guidance of transabdominal B-ultrasound.Embryo; or on day 5, under the guidance of transabdominal B-ultrasound, transplant 1-2 blastocysts; continue to gestrinone 20mg Bid po supports the corpus luteum.
- Pregnancy test: 1)Determination of blood βHCG levels 14 days after ET or Cryopreserved embryo transfer (CET) to determine biochemical pregnancy; 2)If determined to be pregnant, continue corpus luteum support。 3)35 days after ET, determine the clinical pregnancy by transvaginal B-ultrasound, record the number of gestational sacs, location, large Small, the presence or absence of fetal buds, the presence or absence of fetal heart, other abnormal conditions.
- Conditions
- Poor Ovarian Response
- Being tested
- Acupuncture intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture interventionOther
Patients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, he or she will enter the COH cycle at any time.The acupuncture intervention program of the test group is as follows:Acupoint group 1: Baihui(DU20), Zhongyu(RN12), Tianshu (ST25)(bilateral), Guanyuan(RN4), uterus (bilateral)(EX-CA1), Dahe(KI12) (bilateral),Zusanli (ST36)(bilateral), Sanyinjiao(SP6) (bilateral), Taichong (LR3)(both sides).
| Study group | Role | What they receive |
|---|---|---|
| Menstruation situation TCM symptom score standard | Experimental | Not described Receives: Other: Acupuncture intervention |
| Sham intervention | Placebo comparator | Not described Receives: Other: Acupuncture intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of eggs obtained in the COH cycle.
The number of eggs obtained in the controlled ovarian hyperstimulation cycle.
Measured: After an average of 13 days in the COH cycle
Secondary outcomes (3)
Ovarian reserve function assessment
Basal sinus follicle count AFC, AMH and basal hormone levels (package)Including FSH, LH and E2)
Measured: 12 week
Chinese Medicine Symptoms Scoring Standard for Menstruation
Menstrual situation:Mainly assess the menstrual cycle and menstrual flow. menstrual cycle is based on the results of the patient's own comparison.Divided into normal cycle, early menstruation (>7 days before menstruation) and delayed menstruation (>7 days after menstruation) 3class. According to the patient's own comparison results, the menstrual volume is divided into normal menstruation and less menstrual flow.Reduce, or the menstrual period is less than 2 days, or even a drop. It is generally believed that the amount of menstruation is less than 20ml for less menstruation.Class 2.
Measured: 12 week
Self-RatingAnxietyScale
Menstrual disorders, less menstrual flow, hot flashes, night sweats or cold, convulsions, forgetfulness, irritability Insomnia, secondary symptoms include dizziness, tinnitus, dull complexion, waist and knee pain, itchy skin, low libido.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Jan 2018
- Primary completion28 Feb 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Ovarian ResponseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830697
- Sponsor's protocol ID
- 2018-11-29
- Status last verified
- Nov 2018
- First submitted
- 19 Dec 2018
- Last updated
- 21 Mar 2019
- 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 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Trial Was Completed by Shaanxi Provincial Hospital of Traditional Chinese Medicine and Northwest Women and Children's Hospital. Thirty-five Patients With POR Who Underwent ART (Assisted Reproductive) Treatment Were Observed in Each Center. Patients in the Experimental Group Were Given Acupuncture Treatment for 12 Weeks Prior to COH. If the Patient Has a Good COH Timing During Acupuncture Treatment, She Will Enter the COH Cycle at Any Time. Patients in the Control Group Waiting for 12 Weeks Before COH
- ClinicalTrials.gov ID
- NCT03830697
- Acronym / sponsor ID
- 2018-11-29
- Conditions
- Poor Ovarian Response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Shaanxi Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Feb 2019 (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.
The trial was completed by Shaanxi Provincial Hospital of Traditional Chinese Medicine and Northwest Women and Children's Hospital. Thirty-five patients with POR who underwent ART (Assisted Reproductive) treatment were observed in each center. Patients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, she will enter the COH cycle at any time. Patients in the control group waited for 12 weeks before COH. In this study, the COH regimen of the two groups of patients was the same, and the appropriate ovulation induction protocol was selected by the investigator according to the B-ultrasound and endocrine conditions of the patient's menstrual day 1-3. At the end of treatment, patients were observed for the number of eggs in the COH cycle, fertilization rate, cleavage rate, available embryo rate, high quality embryo rate, implantation rate, ovarian reserve function assessment, menstrual status and peri-menopausal symptoms.
Detailed description
1.Acupuncture intervention
- test group Patients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, he or she will enter the COH cycle at any time. The acupuncture intervention program of the test group is as follows: Acupoint group 1: Baihui(DU20), Zhongwan(RN12), Tianshu (ST25)(bilateral), Guanyuan(RN4), uterus (bilateral)(EX-CA1), Dahe(KI12) (bilateral),Zusanli (ST36)(bilateral), Sanyinjiao(SP6) (bilateral), Taichong (LR3)(both sides) Acupoint group 2: Baihui(DU20),ShenShu(BL23)、ZhongLiao(BL33)、TaiXi(KI3) Operation: The two-point group was used alternately, with the group 1 as the initial treatment. The patient took the appropriate position (point group 1 was taken in the supine position, group 2 was taken in the prone position), and the local skin of the acupoint was routinely disinfected. Baihui, flat thorn 0.5-1.0 inch; Tai Chong, acupuncture 0.5-1.0 inch in the direction of Yongquan; Shenshu, Taixi, straight thorn 0.5-1.0 inch; ZhongLiao(BL33) , inward and downward oblique thorn 2.0-2.5 inch, It is required to puncture the hole in the second hole; the remaining hole is straight 1.0-1.5 inch. All the acupoints are evenly inserted and twisted (the Baihui acupoints only turn around). Each time the needle is kept for 20 minutes, once every other day, 3 times a week for a total of 12 weeks.
- Control group Patients in the control group waited for 12 weeks before COH。
2.Standard IVF/ICSI Process
- COH process(In this study, the COH regimen was the same in both groups, and the investigator chose the antagonist regimen based on the B-ultrasound and endocrine conditions on the 1-3 day of menstruation.) 1)Gn start time: Menstruation Day3 days, B-ultrasound and hormone levels (FSH/LH/E2/P/β-HCG) suggest that the ovary is in a basal state; 2)Gn starting dose: 75~300 IU; 3)Gn dose adjustment: 5 days after administration, according to ovarian response (B-ultrasound and E2 levels) Whole Gn dose, hMG (Hemeiqi) can be added if necessary; 1 ovarian response is monitored every 1~2 days thereafter (B-ultrasound and E2 level), adjust the amount of Gn accordingly。 4)When the antagonist is added: when the dominant follicle is ≥12mm, add antagonist (Eugly) 250ug/d to HCG day (including HCG day); 5)HCG trigger timing and dose: at least 3 follicles ≥ 18mm, given HCG4000~8000IUim.
- Eggs taken 36 hours after intramuscular injection of HCG:
- In vitro fertilization, embryo culture:In vitro fertilization was performed 4 to 6 hours after egg retrieval, and Day 3 embryos were scored according to the general standards of each center.The two embryos with the highest score were labeled as the embryos of the first embryo transfer. The remaining embryos are often Freeze on Day3, Day5 or Day6.
- Embryo transfer and corpus luteum support:On Day 3, the patient maintained bladder filling and transplanted 2 of the best quality under the guidance of transabdominal B-ultrasound.Embryo; or on day 5, under the guidance of transabdominal B-ultrasound, transplant 1-2 blastocysts; continue to gestrinone 20mg Bid po supports the corpus luteum.
- Pregnancy test: 1)Determination of blood βHCG levels 14 days after ET or Cryopreserved embryo transfer (CET) to determine biochemical pregnancy; 2)If determined to be pregnant, continue corpus luteum support。 3)35 days after ET, determine the clinical pregnancy by transvaginal B-ultrasound, record the number of gestational sacs, location, large Small, the presence or absence of fetal buds, the presence or absence of fetal heart, other abnormal conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menstruation situation TCM symptom score standard | Experimental | Other: Acupuncture intervention |
| Sham intervention | Placebo comparator | Other: Acupuncture intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- POR compliant diagnostic criteria
- Intracytoplasmic sperm injection, ICSI)。 Indication with IVF or intracytoplasmic sperm injection (ICSI).
- 3.18≤age<40
Key exclusion criteria (7 listed)
- Repeated spontaneous abortion 2 or more patients (including biochemical pregnancy abortion.
- Patients who have failed to undergo repeated implantation (at least 3 transplanted transplants, at least 3-6 high-quality embryos without clinical pregnancy);
- uterine malformation (single uterus, double uterus, double uterus, untreated mediastinal uterus) and other effects affecting uterine cavity disease (adenomyosis, submucosal uterine fibroids, intrauterine adhesions and scar uterus) Patient;
- Patients and their husbands with abnormal karyotypes (excluding chromosomal polymorphisms;
- Untreated patients with hydrosalpinx;
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 |
|---|---|---|
| Acupuncture interventionPatients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, he or she will enter the COH cycle at any time.The acupuncture intervention program of the test group is as follows:Acupoint group 1: Baihui(DU20), Zhongyu(RN12), Tianshu (ST25)(bilateral), Guanyuan(RN4), uterus (bilateral)(EX-CA1), Dahe(KI12) (bilateral),Zusanli (ST36)(bilateral), Sanyinjiao(SP6) (bilateral), Taichong (LR3)(both sides). | Other | Menstruation situation TCM symptom score standard, Sham intervention |
Primary outcome
The number of eggs obtained in the COH cycle.
Time frame: After an average of 13 days in the COH cycle
The number of eggs obtained in the controlled ovarian hyperstimulation cycle.
3 secondary outcomes
Ovarian reserve function assessment
Time frame: 12 week
Chinese Medicine Symptoms Scoring Standard for Menstruation
Time frame: 12 week
Self-RatingAnxietyScale
Time frame: 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
Related trials for Poor Ovarian Response
RecruitingObservational study
Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment
Poor Ovarian Response, Ovarian Reactivation
RecruitingPhase 3
Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST)
Low Ovarian Reserve, Poor Ovarian Response
Not yet recruitingPhase 1/2
Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI
Poor Ovarian Reserve, Infertility (IVF Patients)
Not yet recruiting
The Effects of Coenzyme Q10 Pretreatment on Ovarian Function and Assisted Reproductive Outcomes in Patients With Ovarian Hyporesponsiveness.
Ovarian Response
Not yet recruitingPhase 1/2
Safety and Efficacy of Ubamatamab With First-line Chemotherapy in Ovarian Cancer
Ovarian Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture intervention in people with Poor Ovarian Response, run by Shaanxi Hospital of Traditional Chinese Medicine at 1 site 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 3 inclusion and 7 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Su Tongsheng (15929562568, chinasuts@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of eggs obtained in the COH cycle. (time frame: After an average of 13 days in the COH cycle). 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 21 Mar 2019.