InfertilityNCT02132559
Effect of Dehydroepiandrosterone Administration in Patients With Poor Ovarian Response According to the Bologna Criteria
An observational study of Infertility, run by Chinese Medical Association at 1 site in China.
Trial summary
Women with low ovarian reserve typically respond less well to the drugs used to stimulate the ovary during IVF treatment and produce fewer eggs and, as a result, are less likely to fall pregnant either naturally or after fertility treatment. The ideal stimulation regimen for poor responders is currently unknown. Read more about this study
- Who is it for?
- Ages 23 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- DHEA
- Type of treatment
- Pill or oral medicine
- How many people
- 386 participants
- Where
- 1 siteChina
- Study dates
- Oct 2011to Jul 2013
- Phase
- Observational
- 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 23 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All patients were stratified according to the Bologna criteria for poor ovarian response. Poor responders were classified with at least two of the three following criteria: (I) advanced maternal age (≥40 years) or any other risk factor for POR; (II) a previous POR(≤3 oocytes with a conventional ovarian stimulation protocol); and (III) an abnormal ovarian reserve test (ORT): antral follicle count (AFC) < 5-7 or serum anti-Mullerian hormone (AMH) <0.5-1.1 ng/mL, as described by the Bologna criteria
Who may be able to join
- Patients with poor ovarian response according to the Bologna criteria
Who cannot join
- women aged > 45 years or baseline follicle stimulating hormone(FSH)levels >40 IU/l.
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Women with low ovarian reserve typically respond less well to the drugs used to stimulate the ovary during IVF treatment and produce fewer eggs and, as a result, are less likely to fall pregnant either naturally or after fertility treatment. The ideal stimulation regimen for poor responders is currently unknown.
Dehydroepiandrosterone (DHEA) has been reported to improve pregnancy chances for poor responders, and is now utilized by approximately one third of all IVF centers world-wide. However, the current clinical evidence for DHEA on improvement of ovarian response and IVF outcome is insufficient. The validity of the results of the former studies, especially the varied inclusion criteria used to specify poor responders, is a subject of debate. Recently a uniform definition on poor ovarian response, the Bologna criteria, has been proposed by the European Society for Human Reproduction and Embryology(ESHRE). However, no studies have been performed study to evaluate the potential effects of DHEA supplementation according to these standards.
The purpose of this study is to assess the impact of DHEA supplementation on IVF outcome of poor ovarian responders that fulfill the Bologna criteria.
- Conditions
- Infertility
- Being tested
- DHEA
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHEADrug
Also called dehydroepiandrosterone
| Study group | Role | What they receive |
|---|---|---|
| DHEA administration,no treatment | The patients of study group received DHEA 25 mg orally,three times a day before the IVF cycle. Except for IVF, the control group of patients did not receive any pre-treatment. Receives: Drug: DHEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing pregnancy rates
Measured: 12 weeks after gestation.
Secondary outcomes (5)
Clinical pregnancy rate
Measured: 28 days after the embryo transfer
the number of retrieved oocytes
Measured: 36-37 hrs after hCG administration
Fertilization rate
Measured: on day 1 after oocyte retrieval
Cleavage rate
Measured: on day 2 or 3 after oocyte retrieval
Implantation rate
Measured: 28 days after the embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Guijin Zhu, Study director, Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132559
- Sponsor's protocol ID
- NSFC30901601
- Status last verified
- Jul 2013
- First submitted
- 5 May 2014
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dehydroepiandrosterone Administration in Patients With Poor Ovarian Response According to the Bologna Criteria
- ClinicalTrials.gov ID
- NCT02132559
- Acronym / sponsor ID
- NSFC30901601
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 May 2014 (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.
Women with low ovarian reserve typically respond less well to the drugs used to stimulate the ovary during IVF treatment and produce fewer eggs and, as a result, are less likely to fall pregnant either naturally or after fertility treatment. The ideal stimulation regimen for poor responders is currently unknown.
Dehydroepiandrosterone (DHEA) has been reported to improve pregnancy chances for poor responders, and is now utilized by approximately one third of all IVF centers world-wide. However, the current clinical evidence for DHEA on improvement of ovarian response and IVF outcome is insufficient. The validity of the results of the former studies, especially the varied inclusion criteria used to specify poor responders, is a subject of debate. Recently a uniform definition on poor ovarian response, the Bologna criteria, has been proposed by the European Society for Human Reproduction and Embryology(ESHRE). However, no studies have been performed study to evaluate the potential effects of DHEA supplementation according to these standards.
The purpose of this study is to assess the impact of DHEA supplementation on IVF outcome of poor ovarian responders that fulfill the Bologna criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DHEA administration,no treatment | – | Drug: DHEAThe patients of study group received DHEA 25 mg orally,three times a day before the IVF cycle. Except for IVF, the control group of patients did not receive any pre-treatment. |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients were stratified according to the Bologna criteria for poor ovarian response. Poor responders were classified with at least two of the three following criteria: (I) advanced maternal age (≥40 years) or any other risk factor for POR; (II) a previous POR(≤3 oocytes with a conventional ovarian stimulation protocol); and (III) an abnormal ovarian reserve test (ORT): antral follicle count (AFC) < 5-7 or serum anti-Mullerian hormone (AMH) <0.5-1.1 ng/mL, as described by the Bologna criteria
Key inclusion criteria (1 listed)
- Patients with poor ovarian response according to the Bologna criteria
Key exclusion criteria (1 listed)
- women aged > 45 years or baseline follicle stimulating hormone(FSH)levels >40 IU/l.
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 |
|---|---|---|
| DHEAAlso: dehydroepiandrosterone | Drug | DHEA administration,no treatment |
Primary outcome
ongoing pregnancy rates
Time frame: 12 weeks after gestation.
5 secondary outcomes
Clinical pregnancy rate
Time frame: 28 days after the embryo transfer
the number of retrieved oocytes
Time frame: 36-37 hrs after hCG administration
Fertilization rate
Time frame: on day 1 after oocyte retrieval
Cleavage rate
Time frame: on day 2 or 3 after oocyte retrieval
Implantation rate
Time frame: 28 days after the 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 7 May 2014.
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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.
Guijin Zhu study director
Reproductive Medicine Center, Tongji Hospital, Tongji Medicine College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Chinese Medical Association 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 1 inclusion and 1 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 7 May 2014. 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. 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?
ongoing pregnancy rates (time frame: 12 weeks after gestation.). 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 7 May 2014.