JPRN-jRCTs071180015已完成4 期
Japanese study of the outcome of hormonally controlled FET cycles using OneCrinone as luteal support - Japanese study of the outcome of hormonally controlled FET cycles using OneCrinone as luteal support
Katagiri Yukiko0 个研究点目标入组 181 人开始时间: 2019年1月30日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 181
研究概览
简要总结
In this study, patients used OneCrinone vaginal gel as luteal support in FET cycles. This study suggested that the improvement of pregnancy rate by OneCrinone vaginal gel as a progesterone replacement agent in embryo transfer (ET) after in-vitro fertilization (IVF) is also effective in frozen-thawed embryo transfer (FET) in hormone replacement cycles.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 42age old（—）
- 性别
- Female
入选标准
- •1)Japanese race
- •2)Patients wishing to undergo FET
- •3)Women with transplantable frozen blastocysts (blastocysts classified to grades other than C) who are indicated for FET in hormone replacement cycles
- •4)Healthy premenopausal woman under 42 years of age at the time of ET and wishing to conceive
- •5)Normal cervical cytology within 12 months prior to the date of informed consent [cervical cytology: Negative for Intraepithelial Lesion or Malignancy (NILM) or Atypical Squamous Cells of Undetermined Significance (ASC-US) and Human Papillomavirus (HPV) negative]. The test results can be reported by patients themselves (results must be recorded in the medical record). If results are not available, or if cytology was not performed during this period, cervical cytology and HPV test, if needed, will be performed during the screening period.
- •6)Written informed consent for participation obtained from the patient
- •7)First-time participation in this study.
排除标准
- •1)Natural ovulation may be expected (mature follicles observed).
- •2)History of recurrent pregnancy loss (defined as 3 or more previous spontaneous abortions)
- •3)History of 3 or more consecutive cancelled or failed (no clinical pregnancy) ET cycles.
- •4)Underwent ovarian stimulation using clomiphene citrate in the previous cycle and not having menstruation following oocyte retrieval.
- •5)Abnormal hemorrhage of the reproductive tract of undetermined origin
- •6)Any contraindication to being pregnant and/or carrying a pregnancy to term
- •7)Endometriosis, uterine myoma, adenomyosis uteri, or uterine polyps requiring treatment
- •8)Extra-uterine pregnancy within the last 3 months prior to the date of informed consent
- •9)Ovarian enlargement or cyst of unknown etiology
- •10)Breast-feeding or lactation
- •11)Known Human Immunodeficiency Virus (HIV)-positive status, or a history of or current active infection with Hepatitis B or C.
- •12)History of allergy or hypersensitivity to progesterone preparations and/or their excipients, or any contraindication to receive progesterone preparations
- •13)History of or suspected alcohol or substance abuse within 5 years prior to the date of informed consent
- •14)Active thrombophlebitis, thromboembolic disorder or cerebral stroke, or a history of such conditions.
- •15)Judged as ineligible in the opinion of the site investigator or investigator.
研究者
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