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Many patients couldn't wait for DHEA treatment for three months.
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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.
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) (\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose group | Experimental | dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d.. |
|
| Standard dose group | Other | dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dehydroepiandrosterone | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After taking DHEA for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AFC | Antral follicle count (AFC) | After taking DHEA for 12 weeks |
| Follicle Stimulating Hormone (FSH) Levels | The change of FSH levels in the three groups. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Mature Oocytes Obtained | up to 12 weeks | |
| Pregnancy Rate | The rate of clinical pregnancy | 2 weeks after transfer |
Inclusion Criteria:
Exclusion Criteria:
Patients were excluded if they:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao Xi Sun, PHD,MD | Shang Hai JIAi genetics & IVF center | Study Chair |
| Jing Fu, MD | Shang Hai JIAi genetics & IVF center | Principal Investigator |
| Ying Su Liu, PHD,MD | Shang Hai JIAi Genetics & IVF center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ji Ai Genetics and IVF center | Shanghai | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1761658 | Background | 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. | |
| 12831590 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dose Group | dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d. dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles. |
| FG001 | High Dose Group | dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d.. dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Group | dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d.. dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | oocytes | After taking DHEA for 12 weeks |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose Group | The patients took DHEA 50mg t.i.d. for three months before entering into IVF cycles. |
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The primary outcome measure is oocyte obtained not the IVF clinical pregnancy and the early termination leading to small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Jing Fu | Ji Ai Genetics & IVF Institute | 86-021-63459977 | fujing_givf@163.com |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
| 12 weeks after taking DHEA |
| E2 | Serum E2 levels | 12 weeks after taking DHEA |
| The Number of Follicles>10mm | The number of follicles>10mm represent for the ovarian reserve and response | 12 weeks after taking DHEA |
| AMH | The change of AMH levels in serum | baseline and 12 weeks |
| Testosterone | 12 weeks after taking DHEA |
| Dehydroepiandrosterone-Sulfide (DHEA-S) | 12 weeks after taking DHEA |
| Insulin-like Growth Factor-1 (IGF-1) | 12 weeks after taking DHEA |
| the Numbers of Fertilized Embryos |
| 12 weeks after taking DHEA |
| the Numbers of Cleaved Embryos | After taking DHEA for 12 weeks |
| the Numbers of Top-quality Embryos. | top-quality embryos are represented for >7cell on Day 3 and the fragments <20% | 12 weeks after taking DHEA |
| Ulug 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. |
| 9166190 | Background | Keay 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. |
| 11006185 | Background | Casson 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. |
| 16169414 | Background | Barad 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. |
| 16997936 | Background | Barad 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. |
| 18071895 | Background | Barad 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. |
| 19811650 | Background | Gleicher 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. |
| 19854713 | Background | Hartkamp 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. |
| 9660430 | Background | Casson 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. |
| BG001 | Standard Dose Group | dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d. dehydroepiandrosterone: high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | AFC | Antral follicle count (AFC) | The patients who took DHEA for 12 weeks | Posted | Mean | Standard Error | follicles | After taking DHEA for 12 weeks |
|
|
|
| Secondary | Follicle Stimulating Hormone (FSH) Levels | The change of FSH levels in the three groups. | Posted | Mean | Standard Deviation | IU/L | 12 weeks after taking DHEA |
|
|
|
| Secondary | E2 | Serum E2 levels | Posted | Mean | Standard Deviation | pmol/L | 12 weeks after taking DHEA |
|
|
|
| Secondary | The Number of Follicles>10mm | The number of follicles>10mm represent for the ovarian reserve and response | Posted | Mean | Standard Deviation | follicles | 12 weeks after taking DHEA |
|
|
|
| Secondary | AMH | The change of AMH levels in serum | Posted | Mean | Standard Deviation | ng/ml | baseline and 12 weeks |
|
|
|
| Secondary | Testosterone | Posted | Mean | Standard Deviation | ng/dl | 12 weeks after taking DHEA |
|
|
|
| Secondary | Dehydroepiandrosterone-Sulfide (DHEA-S) | Posted | Mean | Standard Deviation | ug/ml | 12 weeks after taking DHEA |
|
|
|
| Secondary | Insulin-like Growth Factor-1 (IGF-1) | Posted | Mean | Standard Deviation | ng/ml | 12 weeks after taking DHEA |
|
|
|
| Other Pre-specified | The Number of Mature Oocytes Obtained | Posted | Mean | Standard Deviation | oocytes | up to 12 weeks |
|
|
|
| Other Pre-specified | Pregnancy Rate | The rate of clinical pregnancy | Posted | Number | percentage of pregnancy | 2 weeks after transfer |
|
|
|
| Other Pre-specified | the Numbers of Fertilized Embryos | Posted | Mean | Standard Deviation | embryos | 12 weeks after taking DHEA |
|
|
|
| Other Pre-specified | the Numbers of Cleaved Embryos | Posted | Mean | Standard Deviation | embryos | After taking DHEA for 12 weeks |
|
|
|
| Other Pre-specified | the Numbers of Top-quality Embryos. | top-quality embryos are represented for >7cell on Day 3 and the fragments <20% | Posted | Mean | Standard Deviation | embryos | 12 weeks after taking DHEA |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Standard Dose Group | The patients took DHEA 25mg t.i.d. for three months before entering into IVF cycles. | 0 | 30 | 0 | 30 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |