Ignite Creation Date:
2024-05-06 @ 2:38 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02099916
Status:
UNKNOWN
Last Update Posted:
2014-09-10
First Post:
2014-03-26
Brief Title:
Administration of DHEA in Patients With Poor Response to Ovarian Stimulation for IVF
Sponsor:
University of Athens
Organization:
University of Athens
Study Overview
Official Title:
Prospective Randomized Trial on the Effect of DHEA Administration in Women With Poor Ovarian Reserve Undergoing Controlled Ovarian Stimulation for IVF Impact on Stimulation Characteristics and and Pregnancy Outcome
Status:
UNKNOWN
Status Verified Date:
2014-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DHEA
Brief Summary:
Poor responders to ovarian stimulation represents one of the most frustrating problems in reproductive medicine The investigators hypothesize that ovarian response of those patients could improve by treating these patients with 25 mg DHEA tid for 12 weeks prior to stimulation
Detailed Description:
Patients diagnosed with poor ovarian response will be included in the study The definition of poor response was based on the presence of at least one of the following criteria Age 40 years old day 2 FSH 95 mIUml AMH 2ngml at least one previous COH with less than 3 oocytes retrieved at least one cancelled attempt due to poor response estradiol less than 500 pgml on the day of HCG All patients will be counseled regarding their prognosis and other treatment options including oocyte donation as well as adoption were also presented and discussed in detail All patients will be aware that the use of DHEA is experimental and informed consent was obtained for those agreeing to use the medication Women in the DHEA group will receive 25 mg of DHEA three times a day for at least 12 weeks During this period women will be subjected to monthly measurements of early follicular phase FSH and estradiol Anti-Mullerian Hormone AMH will be measured prior to the initiation of treatment and at the end of the observation period Patients will be stimulated with a short GnRH-antagonist protocol Briefly all women will have measurements of serum FSH and estradiol and a pelvic sonogram on the second day of their cycle Providing that serum FSH is 17 mIUml and estradiol is 70 pgml on day 2 ovarian stimulation will be initiated with 450 IU of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH All patients will be re-evaluated on day 5 of the stimulation and dosage adjustments will be made and the antagonists Cetrorelix or ganirelix 025 mgday will be initiated When at least 2 follicles reach an average diameter of 17 mm final oocyte maturation will be triggered with 10000IU of hCG Pregnyl Organon Greece Inc Oocyte retrieval will be performed 34 to 36 hours later All patients will undergo ICSI Patients with successful fertilization will have embryo transfer under sonographic guidance on day 3 after retrieval
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None