EUCTR2010-019411-37-DE进行中（未招募）不适用
A Prospective, Open Label, Randomised, Parallel Group Trial Comparing the Effects of Highly Purified Menotrophin and Recombinant Follicle Stimulating Hormone (rFSH, Follitropin alpha) Administered Subcutaneoulsy to Subfertile Female Patients Undergoing IVF Using Antagonist Down-Regulation on Progesterone Serum Levels During the Follicular Phase and their Possible Use as Predictors for the Success Rate of Ongoing Pregnancies (PREDICT) - PREDICT
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. Signed informed consent
- •2. Subfertile premenopausal female patients eligible for IVF treatment
- •3. Aged >=34 and <= 42 years
- •4. Body mass index of >18 and <28 kg/m2
- •5. Normal pelvic ultrasound at Screening I (Visit 1)
- •6. No more than two previous gonadotrophin stimulated cycles of IVF or ICSI in the history
- •of infertility treatment (gonadotrophin stimulated cycles not used for IVF or ICSI do not
- •count; Clomifen cycles are no exclusion criterion)
- •7. At least 3 consecutive ovulatory menstrual cycles of 24-35 days, and documented evidence of ovulatory cycles within the previous 12 months prior to Screening I
- •8. No fertility stimulating drugs at all within the last 3 months prior to treatment start (Visit 3)
- •9. Sperm of partner classified as normal according to WHO 2010 criteria within the year prior to Visit 3
- •10. Negative urine beta human chorionic gonadotrophin (hCG) pregnancy test at Screening II (Visit 2)
- •11. Clinically normal baseline haematology, clinical chemistry, and urinalysis values at Screening I
- •12. Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests within the last 6 months prior to Screening I
- •13. Endocrine test results (E2, LH, FSH, P4, AMH (>1ng/ml), prolactin, TSH) in early follicular phase within the clinically normal limits at Screening
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Presence of any clinically relevant systemic disease (eg, insulin-dependent diabetes mellitus)
- •2. A history of or current endocrine disease (excluding treated hypothyreosis), including polycystic ovary syndrome (PCOS) and hyperprolactinaemia
- •3. A history of coagulation disorders
- •4. Persistent ovarian cysts (>3 months)
- •5. Contraindications for the use of gonadotrophins or GnRH antagonists
- •6. A history of hypersensitivity to any of the constituents of the study medication or related compounds
- •7. A history of alcohol abuse (more than 30 units per week on a regular basis)
- •8. History of chemo- or radiotherapy
- •9. Currently breast-feeding, pregnant or with a contraindication to pregnancy
- •10. Diagnosed poor (<3 oocytes) responders to prior gonadotrophin stimulated ART-cycle
- •11. History of severe OHSS (grade 4 or 5) in former gonadotrophin stimulated ART-cycle
- •12. Investigational drug within the last 30 days prior to Visit 3 or former enrolment into this study
- •13. Any other condition or history that the Investigator considers might increase the risk to the individual
- •14. Incapability to understand the aim, importance and consequences of the study and to give legal informed consent
- •15. Institutionalization due to regulatory or judicial order
- •16. Possible dependence on the Sponsor or Investigator
研究者
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