Comparison of Vaginal Progesterone Gel (Crinone 8%®) and Intramuscular Progesterone in Vitrified-Warmed Blastocyst Transfer Cycles
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The aim of this study is to test the hypothesis that the pregnancy rates of women (ages 18-50 years) undergoing transfer of vitrified-warmed blastocysts (frozen at less than 41 years of age) as part of their IVF treatment are not different with respect to the administration of progesterone (Crinone® 8% vaginal gel versus intramuscular progesterone).
详细描述
The hypothesis of this study is that the type of progesterone administered (intramuscular progesterone or Crinone® 8% vaginal gel) does not affect implantation and clinical pregnancy rates in women receiving cryo-thawed blastocysts that were produced using their own eggs and frozen before age 41 years. Both intramuscular progesterone (25-100 mg compounded in oil) or vaginal progesterone (Crinone® 8% vaginal progesterone gel) are widely used for luteal phase support in patients receiving vitrified-warmed embryos. Crinone® 8% is FDA approved for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency (FDA approval letter, 1997).
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Patient age at time of embryo freezing: 18 to 40.9 years
- •Patient age at embryo transfer: 18 to 50 years (i.e. women currently ages 18-50 years who are transferring embryos created using eggs retrieved from women aged 18-40.9 years)
- •Blastocysts frozen by vitrification at Brigham and Women's Hospital
- •Standard eligibility criteria for blastocyst transfer at Brigham and Women's Hospital
排除标准
- •Fresh or cleavage-stage embryo transfer planned
- •Gestational carrier cycles
- •Natural and modified natural cycles
- •Embryos frozen more than once or derived from thawed oocytes
- •Embryos frozen at centers other than Brigham and Women's Hospital
- •Embryos frozen using techniques other than vitrification (i.e. slow frozen)
- •Patients with recurrent pregnancy loss, defined as failure of 3 or more clinical pregnancies
- •Uterine factor infertility: Asherman's, submucosal fibroids, polyp greater than 1 cm at time of embryo transfer, uninterrupted hydrosalpinx
- •Patients with three prior failed embryo transfers (fresh or frozen)
- •BMI<18 or >40 kg/m2 at screening
- •Currently breast feeding or pregnant
- •Embryo biopsy performed
- •Current smoking, alcohol or illicit drug use
- •Allergy to study drugs
- •Refusal or inability to adhere to study protocol
- •Participation in other experimental drug trials concurrently within the past 60 days
研究组 & 干预措施
Vaginal progesterone gel (Crinone® 8%)
Crinone® 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) is administered once 5 days prior to embryo transfer, then twice per day until the pregnancy test is negative or until the 10th week of pregnancy.
干预措施: Vaginal progesterone gel (Crinone® 8%) (Drug)
Intramuscular Progesterone
Progesterone-25 mg intramuscularly once 5 days prior to embryo transfer, then 50 mg once per day until the pregnancy test is negative or until the 10th week of pregnancy.
干预措施: Intramuscular Progesterone (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 5-6 weeks
Percentage of patients with intrauterine gestational sac by ultrasound
次要结局
- Ongoing pregnancy rate(7-8 weeks)
- Sustained implantation rate(7 weeks)
- Implantation rate(5-6 weeks)
- Biochemical pregnancy(6 weeks)
研究者
Elena Hesina Yanushpolsky, MD
Assistant Professor, Harvard Medical School
Brigham and Women's Hospital