EUCTR2020-004491-17-BE进行中（未招募）1 期
Dydrogesterone versus micronized vaginal progesterone (MVP) for luteal phase support (LPS) in hormone replacement therapy (HRT) frozen embryo transfer (FET) cycles. - REMODE
Z Brussel0 个研究点目标入组 150 人开始时间: 2021年1月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •=40 years of age at the time of IVF/ICSI treatment
- •BMI =18 to =30 kg/m2 with a documented history of infertility
- •Have undergone COS as part of an ART treatment and have had an unsuccessful fresh embryo transfer in that cycle, OR, have undergone freeze all strategy
- •Scheduled to undergo FET with a standard exogenous/programmed hormonal replacement therapy (HRT) regimen
- •Have at least 1 blastocyst vitrified on the 5th or 6th day after oocyte retrieval
- •Elective single embryo (blastocyst) transfer (SET)
- •Normal ultrasound examination at enrollment (or if <12 months old)
- •Signed patient authorization for use/disclosure of data.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women with a history of recurrent miscarriage, defined as >2 consecutive miscarriages (biochemical pregnancy losses are not included)
- •Absence of implantation (serum hCG = negative) after two consecutive cycles of IVF, ICSI or FET where the cumulative number of transferred embryos was >4 cleavage-stage embryos and >2 blastocysts
- •Presence of hydrosalpinx that is not surgically treated
- •Endometrial abnormalities on scanning during ovarian stimulation, such as endometrial polyp(s), sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid accumulation, or endometrial adhesions
- •Participating in another clinical study at the same time
- •Known allergic reactions to dydrogesterone or other progestogens products
- •Any contraindication or other condition that precludes use of dydrogesterone in a particular patient, in accordance with the precautions listed in the locally approved label
- •Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects in or to complete the study
- •History of prior chemotherapy
- •Contraindication for pregnancy
- •Transfer of >1 embryo
研究者
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