Poor Ovarian ResponseNCT04013984
Acupuncture for Treatment of Patients With Poor Ovarian Response
A study testing Accupuncture in people with Poor Ovarian Response and Accupuncture, run by Royan Institute at 1 site in Iran.
Trial summary
This prospective randomized controlled trial is designed to investigate the effect of acupuncture on IVF/ICSI outcome in women with poor ovarian response. The study population consisted of all infertile women with a previous poor ovarian response who will undergo IVF/ICSI in Reproductive Biomedicine Research Center… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Poor Ovarian Response, Accupuncture
- What is being tested?
- Accupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteIran
- Study dates
- 1 Oct 2018to 20 Jan 2022
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1- Diagnosis of Poor ovarian response (POR), according to POSSEIDON group criteria (Group 3) Young patients (<35 years) with poor ovarian reserve prestimulation parameters (AFC <5, AMH<1.2 ng/mL).
Who cannot join
- Premature ovarian failure diagnosis.
- Endometriosis grade III or IV.
- Any contraindications to ovarian stimulation treatment.
- Uterine infertility factor.
- Previous history of ovarian surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupuncture on in Vitro Fertilization/ Intracytoplasmic Sperm Injection Embryo Transfer (IVF/ICSI-ET) Outcomes in Patients With Poor Ovarian Response Diagnosis: A Randomized Controlled Trial
This prospective randomized controlled trial is designed to investigate the effect of acupuncture on IVF/ICSI outcome in women with poor ovarian response. The study population consisted of all infertile women with a previous poor ovarian response who will undergo IVF/ICSI in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran. To minimize the effect of ovarian stimulation protocol, a stratified randomization method according to ovarian stimulation protocols (GnRH agonist stopped and GnRH antagonist) is used.
Read the detailed description
Poor ovarian response (POR) is a challenging issue in assisted reproduction treatment. Different controlled ovarian hyperstimulation protocols and strategies have been used in this group of women to improve reproductive outcome, but the success rate still remains low. The aim of this study was to determine the effect of acupuncture during ovulation induction on the results of IVF / ICSI cycles in patients with POR diagnosis. The study was approved by the institutional review board. Written, informed consent will be obtained from each participant. Infertile women with a diagnosis of POR, who undergoing the IVF / ICSI cycle are assigned to four groups by stratified randomization method according to ovarian stimulation protocol. Before the starting the treatment cycle, patients will be randomized with sealed randomization envelopes. The random allocation is concealed from the physician performing the IVF/ICSI treatment cycle. All patients will receive acupuncture by the same physician (Dr.Salimi). In experimental groups (A), acupuncture will be applied for 30 minutes in each session and will be started from the month prior to onset of ovarian stimulation (two sessions of a weekly), and during the ovarian stimulation cycle (two sessions of a weekly), totally 7 acupuncture sessions will be carried out. Acupuncture will be performed using sterile needle on specific points (CV 3 (Zhongji), CV 4 (Guanyuan), ST 25 (Tianshu), ST 28 (Shuidao), ST 29 (Guilai), and LR 3 (Taichong), BL 23 (Shenshu), BL 32 (Ciliao), GV 20 (Baihui), GV 24 (Shenting), GB 13 (Benshen), ST 36 (Zusanli), SP 6 Sanyinjiao), SP 8, SP 10 and KI 3 (Taixi)). The needles were inserted to a depth of 15-30 mm, depending on the region of the body. No sham acupuncture is considered in the control group for ethical and practical reasons. There is no intervention in the control groups (B).
Controlled ovarian stimulation for patients in both groups will be performed according the long stopped protocol. GnRH agonist (Buserelin, 0.5 mg), beginning on day 18 of the previous cycle will be used for down regulation and then will be stopped on the starting ovarian stimulation. Ovarian stimulation will be done with recombinant FSH and hMG (225 IU recombinant FSH (Gonal-F®; Serono Laboratories Ltd., Geneva, Switzerland) and 75 IU hMG (Menopur®; Ferring). The doses of gonadotropins were adjusted as ovarian response in the ultrasound monitoring. Ovulation was triggered with hCG (10,000 IU) when at least three follicles have a diameter of 18 mm with an adequate serum E2 concentration.
In both group, transvaginal oocyte retrieval will be performed under ultrasound guidance 32-34 hours after hCG administration. Intracytoplasmic sperm injection will be performed for all metaphase II oocytes. Embryo transfer will be done under ultrasound guidance on day 3 for all patients.
Primary consequences in this study are the total number of retrieved and MII oocytes and quality of the obtained embryos. Secondary outcomes are implantation and clinical pregnancy rates that confirmed by vaginal ultrasound (pregnancy sac and embryonic heart activity). The IVF/ICSI outcomes are compared in four groups. Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS software version 20 for windows.
- Conditions
- Poor Ovarian Response, Accupuncture
- Being tested
- Accupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccupunctureOther
In experimental groups (A), acupuncture will be applied for 30 minutes in each session and will be started from the month prior to onset of ovarian stimulation (two sessions of a weekly), and during the ovarian stimulation cycle (two sessions of a weekly), totally 7 acupuncture sessions will be carried out. Acupuncture will be performed using sterile needle on specific points (CV 3 (Zhongji), CV 4 (Guanyuan), ST 25 (Tianshu), ST 28 (Shuidao), ST 29 (Guilai), and LR 3 (Taichong), BL 23 (Shenshu), BL 32 (Ciliao), GV 20 (Baihui), GV 24 (Shenting), GB 13 (Benshen), ST 36 (Zusanli), SP 6 Sanyinjiao), SP 8, SP 10 and KI 3 (Taixi)). The needles were inserted to a depth of 15-30 mm, depending on the region of the body. No sham acupuncture is considered in the control group for ethical and practical reasons
| Study group | Role | What they receive |
|---|---|---|
| Accupuncture | Experimental | Acupuncture twice a week during the preceding cycle and the ovarian stimulation by "GnRH agonist stopped protocol". Receives: Other: Accupuncture |
| Non-accupuncture | No intervention | Ovarian stimulation by" GnRH agonist stopped protocol" without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of retrieved oocytes
At the point of ovum pick-up, we can count total number of retrieved oocytes. Therefore, in one hour after ovum pick-up, outcome measurement will be possible.
Measured: Day of oocyte pick-up, 34-36 hours after hCG administration (approximately Stimulation Day 10)
Oocyte maturity
At the point of ovum pick-up, we can count how many mature or immature oocytes were retrieved. Therefore, in one hour after ovum pick-up, outcome measurement will be possible.
Measured: Day of oocyte pick-up, 34-36 hours after hCG administration (approximately Stimulation Day 10)
Quality of obtained embryos
Embryo grade assessed under invert microscope 3 days after intracytoplasmic sperm injection procedure [ Time Frame: 3 days after intracytoplasmic sperm injection procedure ] Embryo grade assessed under invert microscope 3 days after intracytoplasmic sperm injection procedure.The quality of embryos was graded from 1 to 3 under inverted microscope 3 days after intracytoplasmic sperm injection procedure. Embryos with even-sized blastomers and/or <5% fragments were classified as Grade 1 (good quality). Grade 2 embryos (moderate quality) had blastomeres with slightly-moderate size differences and/or 5-50% fragments. Grade 3 embryos (poor quality) had markedly different-sized blastomers and/or >50% fragments.
Measured: 3 days after IVF/ICSI procedure
Secondary outcomes (2)
Implantation rate
The ratio of total number of observed gestational sacs to total number of transferred embryos.
Measured: 4 weeks after embryo transfer
Clinical pregnancy rate
The observation of gestational sac with heart beat by using trans-vaginal ulterasound
Measured: 4-6 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Oct 2018
- Primary completion20 Jan 2021
- Study completion20 Jan 2022
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
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013984
- Sponsor's protocol ID
- POR-accupuncure
- Status last verified
- Jun 2023
- First submitted
- 8 Apr 2019
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We can share the results of study, after the publish the manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture on in Vitro Fertilization/ Intracytoplasmic Sperm Injection Embryo Transfer (IVF/ICSI-ET) Outcomes in Patients With Poor Ovarian Response Diagnosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04013984
- Acronym / sponsor ID
- POR-accupuncure
- Conditions
- Poor Ovarian Response, Accupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 10 Jul 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.
This prospective randomized controlled trial is designed to investigate the effect of acupuncture on IVF/ICSI outcome in women with poor ovarian response. The study population consisted of all infertile women with a previous poor ovarian response who will undergo IVF/ICSI in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran. To minimize the effect of ovarian stimulation protocol, a stratified randomization method according to ovarian stimulation protocols (GnRH agonist stopped and GnRH antagonist) is used.
Detailed description
Poor ovarian response (POR) is a challenging issue in assisted reproduction treatment. Different controlled ovarian hyperstimulation protocols and strategies have been used in this group of women to improve reproductive outcome, but the success rate still remains low. The aim of this study was to determine the effect of acupuncture during ovulation induction on the results of IVF / ICSI cycles in patients with POR diagnosis. The study was approved by the institutional review board. Written, informed consent will be obtained from each participant. Infertile women with a diagnosis of POR, who undergoing the IVF / ICSI cycle are assigned to four groups by stratified randomization method according to ovarian stimulation protocol. Before the starting the treatment cycle, patients will be randomized with sealed randomization envelopes. The random allocation is concealed from the physician performing the IVF/ICSI treatment cycle. All patients will receive acupuncture by the same physician (Dr.Salimi). In experimental groups (A), acupuncture will be applied for 30 minutes in each session and will be started from the month prior to onset of ovarian stimulation (two sessions of a weekly), and during the ovarian stimulation cycle (two sessions of a weekly), totally 7 acupuncture sessions will be carried out. Acupuncture will be performed using sterile needle on specific points (CV 3 (Zhongji), CV 4 (Guanyuan), ST 25 (Tianshu), ST 28 (Shuidao), ST 29 (Guilai), and LR 3 (Taichong), BL 23 (Shenshu), BL 32 (Ciliao), GV 20 (Baihui), GV 24 (Shenting), GB 13 (Benshen), ST 36 (Zusanli), SP 6 Sanyinjiao), SP 8, SP 10 and KI 3 (Taixi)). The needles were inserted to a depth of 15-30 mm, depending on the region of the body. No sham acupuncture is considered in the control group for ethical and practical reasons. There is no intervention in the control groups (B).
Controlled ovarian stimulation for patients in both groups will be performed according the long stopped protocol. GnRH agonist (Buserelin, 0.5 mg), beginning on day 18 of the previous cycle will be used for down regulation and then will be stopped on the starting ovarian stimulation. Ovarian stimulation will be done with recombinant FSH and hMG (225 IU recombinant FSH (Gonal-F®; Serono Laboratories Ltd., Geneva, Switzerland) and 75 IU hMG (Menopur®; Ferring). The doses of gonadotropins were adjusted as ovarian response in the ultrasound monitoring. Ovulation was triggered with hCG (10,000 IU) when at least three follicles have a diameter of 18 mm with an adequate serum E2 concentration.
In both group, transvaginal oocyte retrieval will be performed under ultrasound guidance 32-34 hours after hCG administration. Intracytoplasmic sperm injection will be performed for all metaphase II oocytes. Embryo transfer will be done under ultrasound guidance on day 3 for all patients.
Primary consequences in this study are the total number of retrieved and MII oocytes and quality of the obtained embryos. Secondary outcomes are implantation and clinical pregnancy rates that confirmed by vaginal ultrasound (pregnancy sac and embryonic heart activity). The IVF/ICSI outcomes are compared in four groups. Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS software version 20 for windows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Accupuncture | Experimental | Other: AccupunctureAcupuncture twice a week during the preceding cycle and the ovarian stimulation by "GnRH agonist stopped protocol". |
| Non-accupuncture | No intervention | –Ovarian stimulation by" GnRH agonist stopped protocol" without intervention. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1- Diagnosis of Poor ovarian response (POR), according to POSSEIDON group criteria (Group 3) Young patients (<35 years) with poor ovarian reserve prestimulation parameters (AFC <5, AMH<1.2 ng/mL).
Key exclusion criteria (5 listed)
- Premature ovarian failure diagnosis.
- Endometriosis grade III or IV.
- Any contraindications to ovarian stimulation treatment.
- Uterine infertility factor.
- Previous history of ovarian surgery.
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 |
|---|---|---|
| AccupunctureIn experimental groups (A), acupuncture will be applied for 30 minutes in each session and will be started from the month prior to onset of ovarian stimulation (two sessions of a weekly), and during the ovarian stimulation cycle (two sessions of a weekly), totally 7 acupuncture sessions will be carried out. Acupuncture will be performed using sterile needle on specific points (CV 3 (Zhongji), CV 4 (Guanyuan), ST 25 (Tianshu), ST 28 (Shuidao), ST 29 (Guilai), and LR 3 (Taichong), BL 23 (Shenshu), BL 32 (Ciliao), GV 20 (Baihui), GV 24 (Shenting), GB 13 (Benshen), ST 36 (Zusanli), SP 6 Sanyinjiao), SP 8, SP 10 and KI 3 (Taixi)). The needles were inserted to a depth of 15-30 mm, depending on the region of the body. No sham acupuncture is considered in the control group for ethical and practical reasons | Other | Accupuncture |
Primary outcome
Total number of retrieved oocytes
Time frame: Day of oocyte pick-up, 34-36 hours after hCG administration (approximately Stimulation Day 10)
At the point of ovum pick-up, we can count total number of retrieved oocytes. Therefore, in one hour after ovum pick-up, outcome measurement will be possible.
Oocyte maturity
Time frame: Day of oocyte pick-up, 34-36 hours after hCG administration (approximately Stimulation Day 10)
At the point of ovum pick-up, we can count how many mature or immature oocytes were retrieved. Therefore, in one hour after ovum pick-up, outcome measurement will be possible.
Quality of obtained embryos
Time frame: 3 days after IVF/ICSI procedure
Embryo grade assessed under invert microscope 3 days after intracytoplasmic sperm injection procedure [ Time Frame: 3 days after intracytoplasmic sperm injection procedure ] Embryo grade assessed under invert microscope 3 days after intracytoplasmic sperm injection procedure.The quality of embryos was graded from 1 to 3 under inverted microscope 3 days after intracytoplasmic sperm injection procedure. Embryos with even-sized blastomers and/or <5% fragments were classified as Grade 1 (good quality). Grade 2 embryos (moderate quality) had blastomeres with slightly-moderate size differences and/or 5-50% fragments. Grade 3 embryos (poor quality) had markedly different-sized blastomers and/or >50% fragments.
2 secondary outcomes
Implantation rate
Time frame: 4 weeks after embryo transfer
Clinical pregnancy rate
Time frame: 4-6 weeks after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No. We can share the results of study, after the publish the manuscript.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accupuncture in people with Poor Ovarian Response and Accupuncture, run by Royan Institute at 1 site in Iran.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 15 Jun 2023. 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 Iran. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of retrieved oocytes (time frame: Day of oocyte pick-up, 34-36 hours after hCG administration (approximately Stimulation Day 10)). The study lists 3 primary outcomes in all. 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 15 Jun 2023.