DRKS00016163已完成不适用
ELONVA in Programmed Versus Natural Cycle - MISP #56494
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
研究概览
简要总结
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研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 42 Years（—）
- 性别
- Female
入选标准
- •Patients treated by their doctors for ELONVA for infertility in the period 01.11.2015-31.10.2018 (retrospective data collection) must meet the following criteria:
- •1. Patient for whom treatment with corifollitropin alfa is planned in the programmed or natural cycle.
- •2. Patient indicated for IVF and / or ICSI treatment who is willing to have it combined with freshly ejaculated or frozen sperm.
- •3. Patient who is willing and able to follow the treatment regimen.
- •4. Patient who has given her written consent that her patient data may be used for statistical evaluation.
- •In order to ensure statistical comparability of patient data, only data are collected from patients who additionally fulfill the following criteria:
- •5. 18 to (inclusive) 42 years at the time of the preliminary examination
- •6. Body mass index (BMI) = 18 to = 38 kg / m² and body weight = 45 kg to = 95 kg.
- •7. Both ovaries present.
- •8. Serum Concentration of Follicle Stimulating Hormone (FSH) = 12 IU / L measured between day 1 and day 5 in a spontaneous menstrual cycle. Measured within 6 months before the start of treatment.
- •9. Antral follicle number (sum of both ovaries) = 7 to = 20.
- •10. Regular spontaneous menstrual cycle between 21 and 35 days (variation between cycles not more than ± 5 days).
- •11. Normal uterine cavity as determined by transvaginal ultrasound (TVUS) at the preliminary examination. No benign tumors> 4 cm in diameter below the mucous membrane or in the wall, which, in the opinion of the investigator, are in need of treatment to facilitate pregnancy.
排除标准
- •Patients for this non-interventional study were treated according to the discretion of the physician; exclusion criteria are given by contraindications and warnings according to the SmPC.
- •For reasons of statistical comparability of the documented data, data from patients who fulfill any one of the following points at screening will not be included in this analysis:
- •1. Patients who had more than two unsuccessful previous ART cycles (IVF and/or ICSI) before the actual treatment cycle, where unsuccessful is defined as no embryo transfer or no biochemical or clinical pregnancy was achieved. Former ART cycles, which resulted in live birth do not count.
- •2. Previous poor responders: < 3 oocytes retrieved in previous treatment cycles.
- •3. Patients with previous hyperstimulation syndrome or cycle cancellation because of imminent hyperstimulation syndrome.
- •4. Patients with a history of or current polycystic ovarian syndrome (PCOS) according to the Rotterdam consensus criteria (ESHRE, 2004).
- •5. Patients with a history of or current endometriosis III or IV according to the American Society for Reproductive Medicine (ASRM) criteria (ASRM, 1996).
- •6. Presence of ovarian cyst at screening.
- •7. History of = 3 clinical or preclinical (absence of gestational sac) miscarriages.
- •8. Any history of malignant cancer.
- •9. Any endocrine abnormalities requiring treatment (latent hypothyroidism treated by thyroxin is allowed).
- •10. Any clinically significant systematic disease, including history of hormonal abnormali-ties (e.g. Cushing’s syndrome or androgen producing tumours).
- •11. Any known infection with human immunodeficiency virus (HIV), hepatitis B or C.
- •12. History of thrombosis or other risk factors including any coagulation abnormality leading to an increased risk of clotting.
- •13. Use of concomitant medication, which might interfere with IVF and/or ICSI preparation procedures.
- •14. Active smoking (no smoking at all allowed) up to four weeks before Screening in the study.
研究者
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