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

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ClinicalTrials.gov Identifier: NCT02357472
Recruitment Status : Unknown
Verified November 2015 by ShangHai Ji Ai Genetics & IVF Institute.
Recruitment status was:  Active, not recruiting
First Posted : February 6, 2015
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
ShangHai Ji Ai Genetics & IVF Institute

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.


Condition or disease Intervention/treatment Phase
Infertility Drug: dehydroepiandrosterone Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of a Higher Dose of Dehydroepiandrosterone (DHEA) Supplementation on the Number of Oocytes Obtained During IVF in Poor Ovarian Responders
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Prasterone

Arm Intervention/treatment
Experimental: High dose group
dehydroepiandrosterone,DHEA,capsule, 50mg/capsule, one capsule t.i.d..
Drug: 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.
Other Name: DHEA (Lab Hercules™)

Experimental: Standard dose group
dehydroepiandrosterone,DHEA, capsule, 25mg/capsule, one capsule t.i.d.
Drug: 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.
Other Name: DHEA (Lab Hercules™)




Primary Outcome Measures :
  1. The number of oocytes obtained [ Time Frame: up to 12 weeks ]
    After 12 weeks treatment,the change of the number of oocytes obtained from the IVF cycle will be detected among the higher dose group ,normal dose group and placebo group


Secondary Outcome Measures :
  1. Antral follicle count (AFC) [ Time Frame: baseline and 12 weeks ]
    9-10mm follicles

  2. Follicle stimulating hormone (FSH) levels [ Time Frame: baseline and 12 weeks ]
    The change of FSH levels in the three groups.

  3. Estrogen 2 (E2) [ Time Frame: baseline and 12 weeks ]
    Serum and follicular E2 levels

  4. The number of follicles>10mm [ Time Frame: up to 12 weeeks ]
    The number of follicles>10mm represent for the ovarian reserve and response

  5. Antimüllerian hormone ( AMH ) level [ Time Frame: baseline and 12 weeks ]
    The change of AMH levels in serum and follicular fluid

  6. testosterone [ Time Frame: baseline and 12 weeks ]
  7. Dehydroepiandrosterone-Sulfide (DHEA-S) [ Time Frame: baseline and 12 weeks ]
  8. insulin-like growth factor-1 (IGF-1) [ Time Frame: baseline and 12 weeks ]

Other Outcome Measures:
  1. The number of mature oocytes obtained [ Time Frame: up to 12 weeks ]
  2. Pregnancy rate [ Time Frame: 2 weeks after transfer ]
    The rate of clinical pregnancy and ongoing pregnancy

  3. the numbers of fertilized embryos [ Time Frame: up to 12 weeks ]
  4. the numbers of cleaved embryos [ Time Frame: up to 12 weeks ]
  5. the numbers of transferred embryos [ Time Frame: up to 12 weeks ]
  6. the numbers of top-quality embryos. [ Time Frame: up to 12 weeks ]
    top-quality embryos are represented for >7cell on Day 3 and the fragments <20%



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Ages Eligible for Study:   22 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age<45 years,
  2. subfertility >1 year, and
  3. A previous POR (≤3 oocytes with a conventional stimulation protocol of at least 150 IU FSH per day); or
  4. An abnormal ovarian reserve test (i.e. AFC ≤5-7 follicles or AMH ≤0.5-1.1 ng/ml).

Exclusion Criteria:

Patients were excluded if they:

  1. had a history of ovarian cystectomy or oophorectomy,
  2. had received cytotoxic chemotherapy,
  3. had received pelvic irradiation, or
  4. had a history of taking testosterone or DHEA supplementation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357472


Locations
China, Shanghai
Ji Ai Genetics and IVF center
Shang Hai, Shanghai, China, 200011
Sponsors and Collaborators
ShangHai Ji Ai Genetics & IVF Institute
Investigators
Study Chair: Xiao Xi Sun, PHD,MD Shang Hai JIAi genetics & IVF center
Principal Investigator: Jing Fu, MD Shang Hai JIAi genetics & IVF center
Study Director: Ying Su Liu, PHD,MD Shang Hai JIAi Genetics & IVF center

Publications:

Responsible Party: ShangHai Ji Ai Genetics & IVF Institute
ClinicalTrials.gov Identifier: NCT02357472     History of Changes
Other Study ID Numbers: JIAIE2014-03
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by ShangHai Ji Ai Genetics & IVF Institute:
Reproductive aging
DHEA
poor ovarian responder

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs