Hypogonadism; OvarianNCT03080584
Effect of 12 Weeks of Acupuncture on AMH and COH in Low Responder Patients
A study testing acupuncture in people with Hypogonadism; Ovarian and Female Infertility, run by Dansk Fertilitetsklinik at 1 site in Denmark.
Trial summary
the investigators want to study whether 12 weeks of acupuncture has any effect on AMH and the ovarian reserve in women with low ovarian reserve (low responders). AMH is measured before and after 12 weeks of acupuncture and the clinical response to controlled ovarian hyperstimulation before and after the acupuncture is… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypogonadism; Ovarian, Female Infertility
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Nov 2016to 30 Jun 2018
- 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
- IVF/ICSI treatment
- 18-40 years
- AMH measured < or = 10 pmol/l
- maximum of 8 oocytes collected at last treatment before inclusion-
Who cannot join
- (use of testicular sperm)
- more than 4 acupuncture treatments within the last 3 months before inclusion -
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dansk Fertilitetsklinik
Frederiksberg, 2000
Ursula Bentin-Ley, M.D., +45 3834 9030, ursula@danfert.dk
Hans Krog, M.D., +45 3834 9030, hans@danfert.dk
About this study
Official title: Effect of 12 Weeks of Acupuncture on AMH and Ovarian Reserve in Women With Low Ovarian Reserve. A Pilot Study
the investigators want to study whether 12 weeks of acupuncture has any effect on AMH and the ovarian reserve in women with low ovarian reserve (low responders). AMH is measured before and after 12 weeks of acupuncture and the clinical response to controlled ovarian hyperstimulation before and after the acupuncture is compared.
Read the detailed description
AMH is measured cycle day 2 or 3 before and after 12 weeks of acupuncture and the levels are compared. Furthermore, secondary outcomes from IVF treatments before and after the intervention are compared.
- Conditions
- Hypogonadism; Ovarian, Female Infertility
- Being tested
- acupuncture
- Keywords
- acupuncture, IVF, AMH, ovarian reserve
- Medical subject headings
- Hypogonadism, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
12 weeks of acupuncture comprising basic acupuncture, ear acupuncture and Moving cups. On top of the basic acupuncture, additional locations can be added.
| Study group | Role | What they receive |
|---|---|---|
| acupucture arm | Experimental | all participants undergo 12 weeks of acupuncture Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
AMH
anti-Müllerian Hormone level
Measured: chance from baseline after 12 weeks of acupuncture
Secondary outcomes (4)
No. of oocytes aspirated
the number of oocytes collected during egg aspiration for IVF
Measured: change from baseline treatment and after 12 weeks of acupunture
FSH dose/oocyte collected
Measured: change from baseline treatment and after 12 weeks of acupuncture
TQE 44 hours after fertilisation
The number of top quality embryos 44 hours after fertilisation
Measured: change from baseline treatment and after 12 weeks of acupuncture
biobank with blood plasma
Measured: 2 years after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start12 Nov 2016
- Primary completion31 Mar 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypogonadism; OvarianStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- comparison of AMH and ovarian response before and after acupuncture
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dansk Fertilitetsklinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ursula Bentin-Ley, Dansk Fertilitetsklinik
- Investigators
- Ursula Bentin-Ley, M.D., Principal investigator, Dansk Fertilitetsklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080584
- Sponsor's protocol ID
- H-16033980
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2017
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 12 Weeks of Acupuncture on AMH and Ovarian Reserve in Women With Low Ovarian Reserve. A Pilot Study
- ClinicalTrials.gov ID
- NCT03080584
- Acronym / sponsor ID
- H-16033980
- Conditions
- Hypogonadism; Ovarian, Female Infertility
- Keywords
- acupuncture, IVF, AMH, ovarian reserve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dansk FertilitetsklinikUniversity, hospital or other
- Study start
- 12 Nov 2016 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 15 Mar 2017 (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 investigators want to study whether 12 weeks of acupuncture has any effect on AMH and the ovarian reserve in women with low ovarian reserve (low responders). AMH is measured before and after 12 weeks of acupuncture and the clinical response to controlled ovarian hyperstimulation before and after the acupuncture is compared.
Detailed description
AMH is measured cycle day 2 or 3 before and after 12 weeks of acupuncture and the levels are compared. Furthermore, secondary outcomes from IVF treatments before and after the intervention are compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- comparison of AMH and ovarian response before and after acupuncture
| Arm | Type | Receives |
|---|---|---|
| acupucture arm | Experimental | Other: acupunctureall participants undergo 12 weeks of acupuncture |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- IVF/ICSI treatment
- 18-40 years
- AMH measured < or = 10 pmol/l
- maximum of 8 oocytes collected at last treatment before inclusion-
Key exclusion criteria (2 listed)
- (use of testicular sperm)
- more than 4 acupuncture treatments within the last 3 months before inclusion -
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 |
|---|---|---|
| acupuncture12 weeks of acupuncture comprising basic acupuncture, ear acupuncture and Moving cups. On top of the basic acupuncture, additional locations can be added. | Other | acupucture arm |
Primary outcome
AMH
Time frame: chance from baseline after 12 weeks of acupuncture
anti-Müllerian Hormone level
4 secondary outcomes
No. of oocytes aspirated
Time frame: change from baseline treatment and after 12 weeks of acupunture
FSH dose/oocyte collected
Time frame: change from baseline treatment and after 12 weeks of acupuncture
TQE 44 hours after fertilisation
Time frame: change from baseline treatment and after 12 weeks of acupuncture
biobank with blood plasma
Time frame: 2 years after treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- 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.
Ursula Bentin-Ley, M.D. principal investigator
Dansk Fertilitetsklinik
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 in people with Hypogonadism; Ovarian and Female Infertility, run by Dansk Fertilitetsklinik at 1 site in Denmark.
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 4 inclusion and 2 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 16 Mar 2017. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ursula Bentin-Ley, M.D. (+45 3834 9030, ursula@danfert.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH (time frame: chance from baseline after 12 weeks of acupuncture). 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 16 Mar 2017.