The Effect of a Higher Dose of Dehydroepiandrosterone (DHEA) Supplementation in Poor Responders

NCT02357472 | Terminated Results DMC

• 1 other identifier: JIAIE2014-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infertility

Keywords

Reproductive aging; DHEA; poor ovarian responder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• AFC

  After taking DHEA for 12 weeks

• Follicle Stimulating Hormone (FSH) Levels

  12 weeks after taking DHEA

• E2

  12 weeks after taking DHEA

• The Number of Follicles>10mm

  12 weeks after taking DHEA

• AMH

  baseline and 12 weeks

Other Outcomes (5)

• The Number of Mature Oocytes Obtained

  up to 12 weeks

• Pregnancy Rate

  2 weeks after transfer

• the Numbers of Fertilized Embryos

  12 weeks after taking DHEA

Study Arms (2)

High dose group

EXPERIMENTAL

dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..

Dietary Supplement: dehydroepiandrosterone

Standard dose group

OTHER

dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.

Dietary Supplement: dehydroepiandrosterone

Interventions

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.

Also known as: DHEA (Lab Hercules™)

High dose group; Standard dose group

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

Ji Ai Genetics and IVF center

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (10)

• 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.

  PMID: 1761658 BACKGROUND

• 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.

  PMID: 12831590 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.

  PMID: 9166190 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.

  PMID: 11006185 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.

  PMID: 16169414 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.

  PMID: 16997936 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.

  PMID: 18071895 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.

  PMID: 19811650 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.

  PMID: 19854713 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.

  PMID: 9660430 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Limitations and Caveats

The primary outcome measure is oocyte obtained not the IVF clinical pregnancy and the early termination leading to small number of subjects analyzed.

Results Point of Contact

• Title: Dr.Jing Fu
• Organization: Ji Ai Genetics & IVF Institute

fujing_givf@163.com

86-021-63459977

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2015
• First Posted: February 6, 2015
• Study Start: January 1, 2014
• Primary Completion: December 31, 2014
• Study Completion: January 1, 2015
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)