Maximal Stimulation and Delayed Fertilization for Diminished Ovarian Reserve: a Randomized Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Oocytes
研究概览
简要总结
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
详细描述
Women who are not eligible to participate in the CMC Assisted Reproductive Therapy (ART) 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 be "unlinked" from embryo transfer, allowing embryo transfer to occur in a more optimal environment
- Endometrial preparation is routine for frozen embryo transfer Eligible patients will be randomized to one of two protocols: clomiphene + HMG or leuprolide flare protocol.
All subjects must undergo pre-cycle IVF testing as per routine for the CMC ART program. In general, the study will be comprised of subjects not eligible for IVF due to extremely poor prognosis because of expected compromised ovarian stimulation (see inclusion criteria below). Subjects are financially responsible for all treatments in this study. Randomized will be performed by a random number generator after informed consent has been signed. Randomization at this point will allow time to order and obtain required medications.
Cycle start requirements (performed cycle day 2 or 3):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Basal FSH 17 IU/mL (highest ever)
- •Basal FSH 15-17 (highest ever) and failed EFORT test
- •Age > 43 at the time of expected retrieval
- •Failure to conceive with a prior "poor prognosis" IVF stimulation protocol (microdose leuprolide flare or GnRH antagonist cycle) if administered because of evidence of diminished ovarian reserve
- •Failure to conceive with 3 or more IVF cycles at CMC
排除标准
- •Contraindications to IVF
- •Contraindication to pregnancy
- •Allergy or contraindication to medications used for IVF or embryo transfer
- •Use for a gestational carrier
- •Uncorrected or untreatable uterine infertility
- •Smoking or substance abuse within 3 months of initiating stimulation for IVF
研究组 & 干预措施
clomiphene plus gonadotropins
clomiphene plus gonadotropins
干预措施: clomiphene plus gonadotropins (Drug)
Leuprolide flare
Leuprolide flare
干预措施: Leuprolide flare (Drug)
结局指标
主要结局
Oocytes
时间窗: up to 24 months
Number of oocytes retrieved
次要结局
- Number of Oocytes Vitrified(up to 24 months)