Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
The purpose of the study is (A) to determine if the following novel approach improves the
live birth rate with In-Vitro Fertilization (IVF) for women with a poor prognosis due to
diminished ovarian reserve:
- ovarian stimulation with medications that are effective in women with diminished ovarian
reserve but adversely affect the endometrium
- oocyte retrieval and vitrification
- fertilization and embryo transfer in a subsequent cycle with controlled endometrial
preparation B) To determine the optimal stimulation protocol for women with diminished
ovarian reserve incorporating oocyte vitrification
Women who are not eligible to participate in the Carolinas Medical Center (CMC) Assisted
Reproductive Therapy program because of an extremely poor prognosis will be recruited for a
prospective, randomized, open-label study to determine if a novel approach improves the live
birth rate with traditional IVF "poor prognosis" stimulation protocols. The novel approach
will incorporate one of two protocols utilizing medications that provide maximal ovarian
stimulation but have a temporary detrimental fertility-reducing effect on the endometrium. If
ovarian stimulation is adequate, oocyte retrieval will be performed and viable oocytes
vitrified (stored in a "glass-like" state in liquid nitrogen). At a later time, oocyte
warming and fertilization will be performed in a subsequent cycle, in which the endometrium
has been prepared.
Key points include:
- Randomization to one of two ovarian stimulation protocols that have been shown to have a
detrimental effect on the endometrium, and therefore are rarely used in a "fresh" IVF
cycle
- Oocyte vitrification is considered to be an investigational procedure by the American
Society of Reproductive Medicine (ASRM), and should only be performed under the
supervision of an IRB. With oocyte vitrification, ovarian stimulation and oocyte
retrieval can "unlinked" from embryo transfer, allowing embryo transfer to occur in a
more optimal environment
- Endometrial preparation is routine for frozen embryo transfer