EUCTR2018-003556-20-PT进行中（未招募）1 期
How do different ovarian stimulation protocols affect endometrial receptivity during a fresh in vitro fertilization attempt? - RESET (Receptivity Enhancement through Effective Stimulation prior to Transfer) trial
INSTITUTO VALENCIANO DE INFERTILIDADE - CLÍNICA DE REPRODUÇÃO ASSISTIDA, LDA0 个研究点目标入组 24 人开始时间: 2019年4月30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）
- 入组人数
- 24
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
- •1. Informed consent form (ICF) dated and signed.
- •2. Age: =18 and <40 years old.
- •3. Antral follicular count (AFC): =5 and <20.
- •4. Anti-Müllerian Hormone (AMH): =1.1 ng/mL and <2.5 ng/mL, performed in the 12 months prior to inclusion.
- •5. Body Mass Index (BMI): =18.5 Kg/m2 and <30 Kg/m2.
- •6. Weight: =50 kg and <80 kg.
- •7. First or second Assisted Reproductive Technologies (ART) cycle or fertility preservation cycle.
- •8. Regular menstrual cycles (between 22 and 35 days).
- •9. Two ovaries present.
- •10. Pregnancy-wish.
- •11. Planned for single blastocyst transfer
- •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 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Simultaneous participation in another clinical study.
- •2. Previous history of poor ovarian response (<4 oocytes retrieved) with a maximal dose of OS (=300 IU/day) or Ovarian hyperstimulation syndrome (OHSS), regardless of gonadotropin dose.
- •3. Known reasons for impaired implantation (specifically hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis).
- •4. Repeated miscarriages (>2 previous biochemical pregnancies or >2 spontaneous miscarriages).
- •5. Recurrent implantation failure (>3 failed cycles with good quality embryos).
- •6. Polycystic ovary syndrome (PCOS).
- •7. Tumours of the ovary, breast, uterus, pituitary or hypothalamus.
- •8. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- •9. Ovarian cysts or enlarged ovaries.
- •10. Fibroid tumours of the uterus incompatible with pregnancy.
- •11. Malformations of the reproductive organs incompatible with pregnancy.
- •12. Primary gonadal failure.
- •13. Renal impairment defined as estimated glomerular filtration rate of 90 ml/min/1.73 m2 determined by the Modified Diet and Renal Disease (MDRD) equation at screening.
- •14. Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).
- •15. Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia.
- •16. Moderate or severe hepatic impairment.
- •17. Untreated and uncontrolled thyroid dysfunction.
- •18. Current use of oral contraceptive, anti-depressants, anti-psychotics, steroids, anti-epileptics or chemotherapy.
- •19. Administration of exogenous Estradiol (E2), P4 or gonadotropins in the preceding menstrual cycle.
- •20. Active female smoking.
- •21. Acceptors of donated oocytes/embryos.
- •22. Ongoing pregnancy.
- •23. Women who have previously enrolled in the trial.
- •24. Those unable to comprehend the investigational nature of the proposed study.
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