InfertilityDHEANCT02357472
The Effect of a Higher Dose of Dehydroepiandrosterone (DHEA) Supplementation in Poor Responders
A study testing dehydroepiandrosterone in people with Infertility, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
Trial summary
The supplementation of Dehydroepiandrosterone (DHEA) has been used in some centers for patients with previous poor ovarian reserve and response in an attempt to improve pregnancy outcomes. However, there still has controversy on the clinical effect on the 75mg/d for the use,especially in Asian people. Read more about this study
- Who is it for?
- Ages 22 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- dehydroepiandrosterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 1 Jan 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age<45 years,
- subfertility >1 year, and
- A previous POR (≤3 oocytes with a conventional stimulation protocol of at least 150 IU FSH per day); or
- An abnormal ovarian reserve test (i.e. AFC ≤5-7 follicles or AMH ≤0.5-1.1 ng/ml).
Who cannot join
- Patients were excluded if they:
- had a history of ovarian cystectomy or oophorectomy,
- had received cytotoxic chemotherapy,
- had received pelvic irradiation, or
- had a history of taking testosterone or DHEA supplementation
Trial locations and contacts
1 site in 1 country.
China1 site
Ji Ai Genetics and IVF center
Shanghai, Shanghai Municipality, 200011
About this study
Official title: The Effect of a Higher Dose of Dehydroepiandrosterone (DHEA) Supplementation on the Number of Oocytes Obtained During IVF in Poor Ovarian Responders
The supplementation of Dehydroepiandrosterone (DHEA) has been used in some centers for patients with previous poor ovarian reserve and response in an attempt to improve pregnancy outcomes. However, there still has controversy on the clinical effect on the 75mg/d for the use,especially in Asian people. Whether the double dosage of DHEA in patients with poor ovarian reserve and response in China can improve the IVF outcome with little side effect is unknown.
The aim of this randomized controlled study is to compare the effect of a higher dose (150mg daily) and a standard dose (75mg daily) of DHEA on the number of oocytes obtained in poor ovarian responders. The effect of DHEA action on the cumulus cells will be examined.
Read the detailed description
Consecutive infertile women attending the subfertility clinic at Shang Hai Ji Ai Genetics \&IVF Institute for IVF treatment will be approached. Those fulfilling the selection criteria stated below would be recruited and a written consent will be obtained after detailed explanation and counseling.
Poor ovarian responders are defined according to the Bologna criteria fulfilling 2 out of 3 of the following:
(i) Advanced maternal age (>/= 40) or any other genetic or acquired risk factor for poor ovarian response(POR); (ii) Previous poor ovarian response (POR) (</= 3 oocytes with a conventional stimulation protocol using at least 150 international units (IU) gonadotrophins per day) (iii) Abnormal ovarian reserve test [i.e. antral follicle count (AFC) < 5-7 or antimüllerian hormone (AMH) < 0.5 - 1.1ng/ml]
Alternatively, two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ovarian reserve test(ORT).
Baseline assessment will be performed at early follicular phase (Day 2 or 3) at recruitment. Patient characteristics including age, Body Mass Index (BMI), and smoking status would be recorded and blood test including follicular stimulating hormone (FSH), estradiol (E2), testosterone, DHEA-S, full blood count, renal and liver function test would be checked. Pelvic scan will be performed to assess the total AFC and total ovarian volume.
Subjects will be randomized divided into two groups:
- Standard dose group: Subjects will take DHEA (Lab Hercules™) 25mg three times a day for 12 weeks prior to the start of IVF treatment till the day of egg collection.
- High dose group: Subjects will taking DHEA (Lab Hercules™) 50mg three times a day for 12 weeks prior to the start of IVF treatment till the day of egg collection.
Hormonal profile, ultrasound assessment, full blood count, renal and liver function test will be repeated in follicular phase (D2 or 3) of every month or cycle followed by a IVF treatment using antagonist protocol based on our standard departmental regimen. The human menopausal gonadotropin (hMG) injections were started at 300 international units (IU) for 2 days followed by 300 international units (IU) daily. Improvement of ovarian reserve markers would be assessed by the change in serum AMH between the time of recruitment and that after 6 and 12 weeks of DHEA. Cycle characteristics including the dose of gonadotrophins use, duration of stimulation, number of oocytes obtained, number of fertilized embryos and good quality embryos will be recorded and follicular fluid will be saved for hormonal profiles.
Statistics
- Statistical tests Statistical comparisons will be performed according to the intention to treat principle by Student t test or Fisher's exact tests for normally distributed data and Mann-Whitney test for skewed data. Chi-square test would be used for binary variables. Statistical analyses will be performed using the Statistical Package for (the) Social Sciences (SPSS) software and a P-value of 0.05 would be considered statistically significant. Linear regression analysis / logistic regression analysis curve would be used to evaluate the age, BMI, smoking, FSH, E2, AMH, testosterone, DHEA-S, AFC, ovarian volume and duration of DHEA use for the prediction of improved ovarian reserve after DHEA supplementation.
- Sample size estimation
The number of oocytes retrieved will be used as the primary outcome of the study. Based on our own database for patients undergoing IVF treatment, the mean oocytes obtained was 2.7 with a standard deviation (SD) of 1.4. Assuming an increase of oocytes obtained by 1.0 to be clinically significant, 18 subjects in each arm would be required to achieve a test of significance of 0.05 and a power of 0.8. Considering possible dropouts, we aim at recruiting 18 patients in each arm, i.e. 36 patients.
In order to compare one of the secondary outcome -- AMH (which has more relevance on the effect of ovarian response) with adequate power, based on our own database for patients undergoing IVF treatment, the mean AMH of the group with poor ovarian reserve is 0.8 with a SD of 0.6. Assuming an increase of number of oocyte retrieved by 0.5 to be clinically significant, 25 subjects in each arm would be required to achieve a test of significance of 0.01 and a power of 0.9. Totally 50 patients.
- Conditions
- Infertility
- Being tested
- dehydroepiandrosterone
- Keywords
- Reproductive aging, DHEA, poor ovarian responder
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dehydroepiandrosteroneDietary supplement
Also called DHEA (Lab Hercules™)
high dose group treatment represent for 50mg t.i.d. Patients in these group will take one capsule each time and three times a day for three months before entering into IVF cycles.
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Experimental | dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d.. Receives: Dietary Supplement: dehydroepiandrosterone |
| Standard dose group | Other | dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d. Receives: Dietary Supplement: dehydroepiandrosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Oocytes Obtained
After 12 weeks treatment, the number of oocytes obtained will be detected from the higher dose group and standard dose group
Measured: After taking DHEA for 12 weeks
Secondary outcomes (8)
AFC
Antral follicle count (AFC)
Measured: After taking DHEA for 12 weeks
Follicle Stimulating Hormone (FSH) Levels
The change of FSH levels in the three groups.
Measured: 12 weeks after taking DHEA
E2
Serum E2 levels
Measured: 12 weeks after taking DHEA
The Number of Follicles>10mm
The number of follicles>10mm represent for the ovarian reserve and response
Measured: 12 weeks after taking DHEA
AMH
The change of AMH levels in serum
Measured: baseline and 12 weeks
Testosterone
Measured: 12 weeks after taking DHEA
Dehydroepiandrosterone-Sulfide (DHEA-S)
Measured: 12 weeks after taking DHEA
Insulin-like Growth Factor-1 (IGF-1)
Measured: 12 weeks after taking DHEA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study start1 Jan 2014
- Primary completion31 Dec 2014
- Study completion1 Jan 2015
Why it stopped: Many patients couldn't wait for DHEA treatment for three months.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiao Xi Sun, PHD,MD, Study chair, Shang Hai JIAi genetics & IVF centerJing Fu, MD, Principal investigator, Shang Hai JIAi genetics & IVF centerYing Su Liu, PHD,MD, Study director, Shang Hai JIAi Genetics & IVF center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357472
- Sponsor's protocol ID
- JIAIE2014-03
- Acronym
- DHEA
- Status last verified
- Jun 2025
- First submitted
- 17 Jan 2015
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jenkins JM, Davies DW, Devonport H, Anthony FW, Gadd SC, Watson RH, Masson GM. Comparison of 'poor' responders with 'good' responders using a standard buserelin/human menopausal gonadotrophin regime for in-vitro fertilization. Hum Reprod. 1991 Aug;6(7):918-21. doi: 10.1093/oxfordjournals.humrep.a137459.
PubMed 1761658Ulug U, Ben-Shlomo I, Turan E, Erden HF, Akman MA, Bahceci M. Conception rates following assisted reproduction in poor responder patients: a retrospective study in 300 consecutive cycles. Reprod Biomed Online. 2003 Jun;6(4):439-43. doi: 10.1016/s1472-6483(10)62164-5.
PubMed 12831590Keay SD, Liversedge NH, Mathur RS, Jenkins JM. Assisted conception following poor ovarian response to gonadotrophin stimulation. Br J Obstet Gynaecol. 1997 May;104(5):521-7. doi: 10.1111/j.1471-0528.1997.tb11525.x. No abstract available.
PubMed 9166190Casson PR, Lindsay MS, Pisarska MD, Carson SA, Buster JE. Dehydroepiandrosterone supplementation augments ovarian stimulation in poor responders: a case series. Hum Reprod. 2000 Oct;15(10):2129-32. doi: 10.1093/humrep/15.10.2129.
PubMed 11006185Barad DH, Gleicher N. Increased oocyte production after treatment with dehydroepiandrosterone. Fertil Steril. 2005 Sep;84(3):756. doi: 10.1016/j.fertnstert.2005.02.049.
PubMed 16169414Barad D, Gleicher N. Effect of dehydroepiandrosterone on oocyte and embryo yields, embryo grade and cell number in IVF. Hum Reprod. 2006 Nov;21(11):2845-9. doi: 10.1093/humrep/del254. Epub 2006 Sep 22.
PubMed 16997936Barad D, Brill H, Gleicher N. Update on the use of dehydroepiandrosterone supplementation among women with diminished ovarian function. J Assist Reprod Genet. 2007 Dec;24(12):629-34. doi: 10.1007/s10815-007-9178-x. Epub 2007 Dec 11.
PubMed 18071895Gleicher N, Ryan E, Weghofer A, Blanco-Mejia S, Barad DH. Miscarriage rates after dehydroepiandrosterone (DHEA) supplementation in women with diminished ovarian reserve: a case control study. Reprod Biol Endocrinol. 2009 Oct 7;7:108. doi: 10.1186/1477-7827-7-108.
PubMed 19811650Hartkamp A, Geenen R, Godaert GL, Bijl M, Bijlsma JW, Derksen RH. Effects of dehydroepiandrosterone on fatigue and well-being in women with quiescent systemic lupus erythematosus: a randomised controlled trial. Ann Rheum Dis. 2010 Jun;69(6):1144-7. doi: 10.1136/ard.2009.117036. Epub 2009 Oct 22.
PubMed 19854713Casson PR, Santoro N, Elkind-Hirsch K, Carson SA, Hornsby PJ, Abraham G, Buster JE. Postmenopausal dehydroepiandrosterone administration increases free insulin-like growth factor-I and decreases high-density lipoprotein: a six-month trial. Fertil Steril. 1998 Jul;70(1):107-10. doi: 10.1016/s0015-0282(98)00121-6.
PubMed 9660430
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Higher Dose of Dehydroepiandrosterone (DHEA) Supplementation on the Number of Oocytes Obtained During IVF in Poor Ovarian Responders
- ClinicalTrials.gov ID
- NCT02357472
- Acronym / sponsor ID
- DHEA / JIAIE2014-03
- Conditions
- Infertility
- Keywords
- Reproductive aging, DHEA, poor ovarian responder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Many patients couldn't wait for DHEA treatment for three months.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF InstituteUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The supplementation of Dehydroepiandrosterone (DHEA) has been used in some centers for patients with previous poor ovarian reserve and response in an attempt to improve pregnancy outcomes. However, there still has controversy on the clinical effect on the 75mg/d for the use,especially in Asian people. Whether the double dosage of DHEA in patients with poor ovarian reserve and response in China can improve the IVF outcome with little side effect is unknown.
The aim of this randomized controlled study is to compare the effect of a higher dose (150mg daily) and a standard dose (75mg daily) of DHEA on the number of oocytes obtained in poor ovarian responders. The effect of DHEA action on the cumulus cells will be examined.
Detailed description
Consecutive infertile women attending the subfertility clinic at Shang Hai Ji Ai Genetics \&IVF Institute for IVF treatment will be approached. Those fulfilling the selection criteria stated below would be recruited and a written consent will be obtained after detailed explanation and counseling.
Poor ovarian responders are defined according to the Bologna criteria fulfilling 2 out of 3 of the following:
(i) Advanced maternal age (>/= 40) or any other genetic or acquired risk factor for poor ovarian response(POR); (ii) Previous poor ovarian response (POR) (</= 3 oocytes with a conventional stimulation protocol using at least 150 international units (IU) gonadotrophins per day) (iii) Abnormal ovarian reserve test [i.e. antral follicle count (AFC) < 5-7 or antimüllerian hormone (AMH) < 0.5 - 1.1ng/ml]
Alternatively, two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ovarian reserve test(ORT).
Baseline assessment will be performed at early follicular phase (Day 2 or 3) at recruitment. Patient characteristics including age, Body Mass Index (BMI), and smoking status would be recorded and blood test including follicular stimulating hormone (FSH), estradiol (E2), testosterone, DHEA-S, full blood count, renal and liver function test would be checked. Pelvic scan will be performed to assess the total AFC and total ovarian volume.
Subjects will be randomized divided into two groups:
- Standard dose group: Subjects will take DHEA (Lab Hercules™) 25mg three times a day for 12 weeks prior to the start of IVF treatment till the day of egg collection.
- High dose group: Subjects will taking DHEA (Lab Hercules™) 50mg three times a day for 12 weeks prior to the start of IVF treatment till the day of egg collection.
Hormonal profile, ultrasound assessment, full blood count, renal and liver function test will be repeated in follicular phase (D2 or 3) of every month or cycle followed by a IVF treatment using antagonist protocol based on our standard departmental regimen. The human menopausal gonadotropin (hMG) injections were started at 300 international units (IU) for 2 days followed by 300 international units (IU) daily. Improvement of ovarian reserve markers would be assessed by the change in serum AMH between the time of recruitment and that after 6 and 12 weeks of DHEA. Cycle characteristics including the dose of gonadotrophins use, duration of stimulation, number of oocytes obtained, number of fertilized embryos and good quality embryos will be recorded and follicular fluid will be saved for hormonal profiles.
Statistics
- Statistical tests Statistical comparisons will be performed according to the intention to treat principle by Student t test or Fisher's exact tests for normally distributed data and Mann-Whitney test for skewed data. Chi-square test would be used for binary variables. Statistical analyses will be performed using the Statistical Package for (the) Social Sciences (SPSS) software and a P-value of 0.05 would be considered statistically significant. Linear regression analysis / logistic regression analysis curve would be used to evaluate the age, BMI, smoking, FSH, E2, AMH, testosterone, DHEA-S, AFC, ovarian volume and duration of DHEA use for the prediction of improved ovarian reserve after DHEA supplementation.
- Sample size estimation
The number of oocytes retrieved will be used as the primary outcome of the study. Based on our own database for patients undergoing IVF treatment, the mean oocytes obtained was 2.7 with a standard deviation (SD) of 1.4. Assuming an increase of oocytes obtained by 1.0 to be clinically significant, 18 subjects in each arm would be required to achieve a test of significance of 0.05 and a power of 0.8. Considering possible dropouts, we aim at recruiting 18 patients in each arm, i.e. 36 patients.
In order to compare one of the secondary outcome -- AMH (which has more relevance on the effect of ovarian response) with adequate power, based on our own database for patients undergoing IVF treatment, the mean AMH of the group with poor ovarian reserve is 0.8 with a SD of 0.6. Assuming an increase of number of oocyte retrieved by 0.5 to be clinically significant, 25 subjects in each arm would be required to achieve a test of significance of 0.01 and a power of 0.9. Totally 50 patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose group | Experimental | Dietary Supplement: dehydroepiandrosteronedehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d.. |
| Standard dose group | Other | Dietary Supplement: dehydroepiandrosteronedehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age<45 years,
- subfertility >1 year, and
- A previous POR (≤3 oocytes with a conventional stimulation protocol of at least 150 IU FSH per day); or
- An abnormal ovarian reserve test (i.e. AFC ≤5-7 follicles or AMH ≤0.5-1.1 ng/ml).
Key exclusion criteria (5 listed)
- had a history of ovarian cystectomy or oophorectomy,
- had received cytotoxic chemotherapy,
- had received pelvic irradiation, or
- had a history of taking testosterone or DHEA supplementation
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 |
|---|---|---|
| dehydroepiandrosteroneAlso: DHEA (Lab Hercules™)high dose group treatment represent for 50mg t.i.d. Patients in these group will take one capsule each time and three times a day for three months before entering into IVF cycles. | Dietary supplement | High dose group, Standard dose group |
Primary outcome
The Number of Oocytes Obtained
Time frame: After taking DHEA for 12 weeks
After 12 weeks treatment, the number of oocytes obtained will be detected from the higher dose group and standard dose group
8 secondary outcomes
AFC
Time frame: After taking DHEA for 12 weeks
Follicle Stimulating Hormone (FSH) Levels
Time frame: 12 weeks after taking DHEA
E2
Time frame: 12 weeks after taking DHEA
The Number of Follicles>10mm
Time frame: 12 weeks after taking DHEA
AMH
Time frame: baseline and 12 weeks
Testosterone
Time frame: 12 weeks after taking DHEA
Dehydroepiandrosterone-Sulfide (DHEA-S)
Time frame: 12 weeks after taking DHEA
Insulin-like Growth Factor-1 (IGF-1)
Time frame: 12 weeks after taking DHEA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1761658Jenkins JM, Davies DW, Devonport H, Anthony FW, Gadd SC, Watson RH, Masson GM. Comparison of 'poor' responders with 'good' responders using a standard buserelin/human menopausal gonadotrophin regime for in-vitro fertilization. Hum Reprod. 1991 Aug;6(7):918-21. doi: 10.1093/oxfordjournals.humrep.a137459.
- Background: PubMed 12831590Ulug U, Ben-Shlomo I, Turan E, Erden HF, Akman MA, Bahceci M. Conception rates following assisted reproduction in poor responder patients: a retrospective study in 300 consecutive cycles. Reprod Biomed Online. 2003 Jun;6(4):439-43. doi: 10.1016/s1472-6483(10)62164-5.
- Background: PubMed 9166190Keay SD, Liversedge NH, Mathur RS, Jenkins JM. Assisted conception following poor ovarian response to gonadotrophin stimulation. Br J Obstet Gynaecol. 1997 May;104(5):521-7. doi: 10.1111/j.1471-0528.1997.tb11525.x. No abstract available.
- Background: PubMed 11006185Casson PR, Lindsay MS, Pisarska MD, Carson SA, Buster JE. Dehydroepiandrosterone supplementation augments ovarian stimulation in poor responders: a case series. Hum Reprod. 2000 Oct;15(10):2129-32. doi: 10.1093/humrep/15.10.2129.
- Background: PubMed 16169414Barad DH, Gleicher N. Increased oocyte production after treatment with dehydroepiandrosterone. Fertil Steril. 2005 Sep;84(3):756. doi: 10.1016/j.fertnstert.2005.02.049.
- Background: PubMed 16997936Barad D, Gleicher N. Effect of dehydroepiandrosterone on oocyte and embryo yields, embryo grade and cell number in IVF. Hum Reprod. 2006 Nov;21(11):2845-9. doi: 10.1093/humrep/del254. Epub 2006 Sep 22.
- Background: PubMed 18071895Barad D, Brill H, Gleicher N. Update on the use of dehydroepiandrosterone supplementation among women with diminished ovarian function. J Assist Reprod Genet. 2007 Dec;24(12):629-34. doi: 10.1007/s10815-007-9178-x. Epub 2007 Dec 11.
- Background: PubMed 19811650Gleicher N, Ryan E, Weghofer A, Blanco-Mejia S, Barad DH. Miscarriage rates after dehydroepiandrosterone (DHEA) supplementation in women with diminished ovarian reserve: a case control study. Reprod Biol Endocrinol. 2009 Oct 7;7:108. doi: 10.1186/1477-7827-7-108.
- Background: PubMed 19854713Hartkamp A, Geenen R, Godaert GL, Bijl M, Bijlsma JW, Derksen RH. Effects of dehydroepiandrosterone on fatigue and well-being in women with quiescent systemic lupus erythematosus: a randomised controlled trial. Ann Rheum Dis. 2010 Jun;69(6):1144-7. doi: 10.1136/ard.2009.117036. Epub 2009 Oct 22.
- Background: PubMed 9660430Casson PR, Santoro N, Elkind-Hirsch K, Carson SA, Hornsby PJ, Abraham G, Buster JE. Postmenopausal dehydroepiandrosterone administration increases free insulin-like growth factor-I and decreases high-density lipoprotein: a six-month trial. Fertil Steril. 1998 Jul;70(1):107-10. doi: 10.1016/s0015-0282(98)00121-6.
- 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.
Xiao Xi Sun, PHD,MD study chair
Shang Hai JIAi genetics & IVF center
Jing Fu, MD principal investigator
Shang Hai JIAi genetics & IVF center
Ying Su Liu, PHD,MD study director
Shang Hai JIAi Genetics & IVF center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dehydroepiandrosterone in people with Infertility, run by ShangHai Ji Ai Genetics & IVF Institute 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 4 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: stopped early, as of the sponsor's last update on 24 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Oocytes Obtained (time frame: After taking DHEA for 12 weeks). 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 NCT02357472, which also lists 10 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 24 Jun 2025.