SubfertilityNCT02432248
Effect of DHEA on Patients With Poor Ovarian Responds
A study testing Dehydroepiandrosterone in people with Subfertility, run by The Affiliated Hospital of Inner Mongolia Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate the effect of DHEA for treatment of subfertile patients with poor ovarian reserve and post-treatment evaluation of IVF outcome. Read more about this study
- Who is it for?
- Ages 21 to 42 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Dehydroepiandrosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Dec 2024
- 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 21 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Indicated for IVF treatment according to our standard department protocol
- Age < 42
- Regular menstrual cycles (21-35 days)
- Poor ovarian responders are defined according to the Bologna criteria fulfilling 2 out of 3 of the following:
- Advanced maternal age (≥40) or any other genetic or acquired risk factor for POR
- Previous poor ovarian response (POR) (≤3 oocytes with a conventional stimulation protocol using at least 150IU gonadotrophins per day)
- Abnormal ovarian reserve test (i.e. AFC < 5-7 or 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 ORT.
Who cannot join
- Previous chemotherapy or pelvic irradiation
- Polycystic ovarian syndrome or polycystic ovaries
- On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Inner Mongolia
Yu Wang, MD
About this study
Official title: Effect of Dehydroepiandrosterone on Live Birth Rate in Subfertile Patients With Poor Ovarian Responds
The purpose of this study is to investigate the effect of DHEA for treatment of subfertile patients with poor ovarian reserve and post-treatment evaluation of IVF outcome.
Read the detailed description
The aim of this randomized controlled study is to compare the effect of DHEA and placebo on live birth rate in poor ovarian responders. Consecutive infertile women attending the subfertility clinic for IVF treatment will be approached. Those fulfilling the selection criteria would be recruited and a written consent will be obtained after detailed explanation and counseling.
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 and anti-Müllerian hormone (AMH) would be checked. Pelvic scan will be performed to assess the total antral follicle count (AFC) and total ovarian volume.
Subjects will be randomized divided into two groups:
- DHEA group: Subjects will take DHEA (Vitacost) 25mg three times a day for 12 weeks prior to the start of IVF treatment.
- Placebo group: Subjects will take placebo three times a day for 12 weeks prior to the start of IVF treatment.
Ultrasound assessment 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. 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.
- Conditions
- Subfertility
- Being tested
- Dehydroepiandrosterone, placebo(medical starch)
- Keywords
- DHEA, live birth rate, 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.
DehydroepiandrosteroneDrug
Also called DHEA
75mg/day, PO for 90 days
placebo(medical starch)Other
75mg/day, PO for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Dehydroepiandrosterone | Experimental | DHEA is considered as health supplement and is available over the counter. Side effects are minimal at present dosage (25mg or 50mg tds). Receives: Drug: Dehydroepiandrosterone |
| Placebo | Placebo comparator | Medical starch is considered as medicine components. Side effects are minimal at present dosage. Receives: Other: placebo(medical starch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Compare the live birth rate between DHEA group and placebo group
Measured: Participants will be followed for live birth rate up to 1 year.
Secondary outcomes (1)
Pregnancy rate
Compare the pregnancy rate between DHEA group and placebo group
Measured: Participants will be followed for pregnancy rate up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for SubfertilityStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Renmin Hospital of Wuhan University
- Responsible party
- Sponsor
- Investigators
- Yu Wang, PHD, Principal investigator, The Affiliated Hospital of Inner Mongolia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432248
- Sponsor's protocol ID
- S00056W9
- Status last verified
- Jul 2023
- First submitted
- 17 Mar 2015
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Ubaldi FM, Rienzi L, Ferrero S, Baroni E, Sapienza F, Cobellis L, Greco E. Management of poor responders in IVF. Reprod Biomed Online. 2005 Feb;10(2):235-46. doi: 10.1016/s1472-6483(10)60946-7.
PubMed 15823231Arlt W, Justl HG, Callies F, Reincke M, Hubler D, Oettel M, Ernst M, Schulte HM, Allolio B. Oral dehydroepiandrosterone for adrenal androgen replacement: pharmacokinetics and peripheral conversion to androgens and estrogens in young healthy females after dexamethasone suppression. J Clin Endocrinol Metab. 1998 Jun;83(6):1928-34. doi: 10.1210/jcem.83.6.4850.
PubMed 9626121Shifren JL, Braunstein GD, Simon JA, Casson PR, Buster JE, Redmond GP, Burki RE, Ginsburg ES, Rosen RC, Leiblum SR, Caramelli KE, Mazer NA. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med. 2000 Sep 7;343(10):682-8. doi: 10.1056/NEJM200009073431002.
PubMed 10974131Gleicher N, Weghofer A, Barad DH. The role of androgens in follicle maturation and ovulation induction: friend or foe of infertility treatment? Reprod Biol Endocrinol. 2011 Aug 17;9:116. doi: 10.1186/1477-7827-9-116.
PubMed 21849061Zhang HH, Xu PY, Wu J, Zou WW, Xu XM, Cao XY, Wei LZ. Dehydroepiandrosterone improves follicular fluid bone morphogenetic protein-15 and accumulated embryo score of infertility patients with diminished ovarian reserve undergoing in vitro fertilization: a randomized controlled trial. J Ovarian Res. 2014 Oct 21;7:93. doi: 10.1186/s13048-014-0093-3.
PubMed 25330837Gleicher N, Weghofer A, Barad DH. Defining ovarian reserve to better understand ovarian aging. Reprod Biol Endocrinol. 2011 Feb 7;9:23. doi: 10.1186/1477-7827-9-23.
PubMed 21299886Casson 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 9660430Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
PubMed 21505041Mutlu MF, Erdem M, Erdem A, Yildiz S, Mutlu I, Arisoy O, Oktem M. Antral follicle count determines poor ovarian response better than anti-Mullerian hormone but age is the only predictor for live birth in in vitro fertilization cycles. J Assist Reprod Genet. 2013 Jun;30(5):657-65. doi: 10.1007/s10815-013-9975-3. Epub 2013 Mar 19.
PubMed 23508679Gleicher N, Barad DH. Dehydroepiandrosterone (DHEA) supplementation in diminished ovarian reserve (DOR). Reprod Biol Endocrinol. 2011 May 17;9:67. doi: 10.1186/1477-7827-9-67.
PubMed 21586137Casson 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 11006185Mamas L, Mamas E. Dehydroepiandrosterone supplementation in assisted reproduction: rationale and results. Curr Opin Obstet Gynecol. 2009 Aug;21(4):306-8. doi: 10.1097/gco.0b013e32832e0785.
PubMed 19610174Sunkara SK, Pundir J, Khalaf Y. Effect of androgen supplementation or modulation on ovarian stimulation outcome in poor responders: a meta-analysis. Reprod Biomed Online. 2011 Jun;22(6):545-55. doi: 10.1016/j.rbmo.2011.01.015. Epub 2011 Feb 17.
PubMed 21493151Gleicher N, Weghofer A, Barad DH. Dehydroepiandrosterone (DHEA) reduces embryo aneuploidy: direct evidence from preimplantation genetic screening (PGS). Reprod Biol Endocrinol. 2010 Nov 10;8:140. doi: 10.1186/1477-7827-8-140.
PubMed 21067609Ferrario M, Secomandi R, Cappato M, Galbignani E, Frigerio L, Arnoldi M, Fusi FM. Ovarian and adrenal androgens may be useful markers to predict oocyte competence and embryo development in older women. Gynecol Endocrinol. 2015 Feb;31(2):125-30. doi: 10.3109/09513590.2014.964639. Epub 2014 Sep 26.
PubMed 25259725
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dehydroepiandrosterone on Live Birth Rate in Subfertile Patients With Poor Ovarian Responds
- ClinicalTrials.gov ID
- NCT02432248
- Acronym / sponsor ID
- S00056W9
- Conditions
- Subfertility
- Keywords
- DHEA, live birth rate, poor ovarian responder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Renmin Hospital of Wuhan University
- Study start
- Feb 2015
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 May 2015 (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.
The purpose of this study is to investigate the effect of DHEA for treatment of subfertile patients with poor ovarian reserve and post-treatment evaluation of IVF outcome.
Detailed description
The aim of this randomized controlled study is to compare the effect of DHEA and placebo on live birth rate in poor ovarian responders. Consecutive infertile women attending the subfertility clinic for IVF treatment will be approached. Those fulfilling the selection criteria would be recruited and a written consent will be obtained after detailed explanation and counseling.
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 and anti-Müllerian hormone (AMH) would be checked. Pelvic scan will be performed to assess the total antral follicle count (AFC) and total ovarian volume.
Subjects will be randomized divided into two groups:
- DHEA group: Subjects will take DHEA (Vitacost) 25mg three times a day for 12 weeks prior to the start of IVF treatment.
- Placebo group: Subjects will take placebo three times a day for 12 weeks prior to the start of IVF treatment.
Ultrasound assessment 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dehydroepiandrosterone | Experimental | Drug: DehydroepiandrosteroneDHEA is considered as health supplement and is available over the counter. Side effects are minimal at present dosage (25mg or 50mg tds). |
| Placebo | Placebo comparator | Other: placebo(medical starch)Medical starch is considered as medicine components. Side effects are minimal at present dosage. |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Indicated for IVF treatment according to our standard department protocol
- Age < 42
- Regular menstrual cycles (21-35 days)
- Poor ovarian responders are defined according to the Bologna criteria fulfilling 2 out of 3 of the following:
- Advanced maternal age (≥40) or any other genetic or acquired risk factor for POR
Key exclusion criteria (3 listed)
- Previous chemotherapy or pelvic irradiation
- Polycystic ovarian syndrome or polycystic ovaries
- On hormonal supplementation for any indication at the time of recruitment (e.g. estrogen, testosterone or DHEA)
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: DHEA75mg/day, PO for 90 days | Drug | Dehydroepiandrosterone |
| placebo(medical starch)75mg/day, PO for 90 days | Other | Placebo |
Primary outcome
Live birth rate
Time frame: Participants will be followed for live birth rate up to 1 year.
Compare the live birth rate between DHEA group and placebo group
1 secondary outcome
Pregnancy rate
Time frame: Participants will be followed for pregnancy rate up to 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Background: PubMed 15823231Ubaldi FM, Rienzi L, Ferrero S, Baroni E, Sapienza F, Cobellis L, Greco E. Management of poor responders in IVF. Reprod Biomed Online. 2005 Feb;10(2):235-46. doi: 10.1016/s1472-6483(10)60946-7.
- Background: PubMed 9626121Arlt W, Justl HG, Callies F, Reincke M, Hubler D, Oettel M, Ernst M, Schulte HM, Allolio B. Oral dehydroepiandrosterone for adrenal androgen replacement: pharmacokinetics and peripheral conversion to androgens and estrogens in young healthy females after dexamethasone suppression. J Clin Endocrinol Metab. 1998 Jun;83(6):1928-34. doi: 10.1210/jcem.83.6.4850.
- Background: PubMed 10974131Shifren JL, Braunstein GD, Simon JA, Casson PR, Buster JE, Redmond GP, Burki RE, Ginsburg ES, Rosen RC, Leiblum SR, Caramelli KE, Mazer NA. Transdermal testosterone treatment in women with impaired sexual function after oophorectomy. N Engl J Med. 2000 Sep 7;343(10):682-8. doi: 10.1056/NEJM200009073431002.
- Background: PubMed 21849061Gleicher N, Weghofer A, Barad DH. The role of androgens in follicle maturation and ovulation induction: friend or foe of infertility treatment? Reprod Biol Endocrinol. 2011 Aug 17;9:116. doi: 10.1186/1477-7827-9-116.
- Background: PubMed 25330837Zhang HH, Xu PY, Wu J, Zou WW, Xu XM, Cao XY, Wei LZ. Dehydroepiandrosterone improves follicular fluid bone morphogenetic protein-15 and accumulated embryo score of infertility patients with diminished ovarian reserve undergoing in vitro fertilization: a randomized controlled trial. J Ovarian Res. 2014 Oct 21;7:93. doi: 10.1186/s13048-014-0093-3.
- Background: PubMed 21299886Gleicher N, Weghofer A, Barad DH. Defining ovarian reserve to better understand ovarian aging. Reprod Biol Endocrinol. 2011 Feb 7;9:23. doi: 10.1186/1477-7827-9-23.
- 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.
- Background: PubMed 21505041Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
- Background: PubMed 23508679Mutlu MF, Erdem M, Erdem A, Yildiz S, Mutlu I, Arisoy O, Oktem M. Antral follicle count determines poor ovarian response better than anti-Mullerian hormone but age is the only predictor for live birth in in vitro fertilization cycles. J Assist Reprod Genet. 2013 Jun;30(5):657-65. doi: 10.1007/s10815-013-9975-3. Epub 2013 Mar 19.
- Background: PubMed 21586137Gleicher N, Barad DH. Dehydroepiandrosterone (DHEA) supplementation in diminished ovarian reserve (DOR). Reprod Biol Endocrinol. 2011 May 17;9:67. doi: 10.1186/1477-7827-9-67.
- 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 19610174Mamas L, Mamas E. Dehydroepiandrosterone supplementation in assisted reproduction: rationale and results. Curr Opin Obstet Gynecol. 2009 Aug;21(4):306-8. doi: 10.1097/gco.0b013e32832e0785.
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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.
Yu Wang, PHD principal investigator
The Affiliated Hospital of Inner Mongolia Medical University
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 Subfertility, run by The Affiliated Hospital of Inner Mongolia Medical University 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 7 inclusion and 3 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 20 Jul 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 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 Yu Wang, PHD (86-18604718958, wuai1544@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: Participants will be followed for live birth rate up to 1 year.). 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 NCT02432248, which also lists 32 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 20 Jul 2023.