Clinical Trial: Administration of DHEA in Patients With Poor Response to Ovarian Stimulation for IVF

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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 Pr

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 Summary: 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 >9.5 mIU/ml, AMH < 2ng/ml ,at least one previous COH with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml 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 mIU/ml and estradiol is < 70 pg/ml 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 0.25 mg/day) will be initiated. When at least 2 follicles reach an average diameter of 17 mm, final oocyte maturation will be triggered with 10,000IU 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 tra
Sponsor: University of Athens

Current Primary Outcome: clinical pregnancy [ Time Frame: At 12 weeks after DHEA administration and at 18 months ]

At the completion of the ovarian stimulation patients that will proceed to transfer and have a positive pregnancy test will have sonographic evaluation for confirmation of clinical pregnancy.


Original Primary Outcome: clinical pregnancy [ Time Frame: 18 months ]

At the completion of the ovarian stimulation patients that will proceed to transfer and have a positive pregnancy test will have sonographic evaluation for confirmation of clinical pregnancy.


Current Secondary Outcome: changes in ovarian reserve indexes [ Time Frame: 6 months ]

Original Secondary Outcome: Same as current

Information By: University of Athens

Dates:
Date Received: March 26, 2014
Date Started: October 2014
Date Completion: December 2015
Last Updated: September 9, 2014
Last Verified: September 2014