NL-OMON52678已完成3 期
A randomised, controlled, open label, parallel group, multicentre trial comparing the efficacy and safety of individualised FE 999049 (follitropin delta) dosing, using a long GnRH agonist protocol and a GnRH antagonist protocol in women undergoing controlled ovarian stimulation - BEYOND
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ferring
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Informed Consent Documents signed prior to screening evaluations., 2. In
- •good physical and mental health. , 3. The subjects must be at least 18 years
- •(including the 18th birthday) when they sign the informed consent and no more
- •than 40 years (up to the day before the 41st birthday) at the time of
- •randomisation., 4. Infertile women diagnosed with tubal infertility,
- •unexplained infertility, endometriosis stage I/II or with partners diagnosed
- •with male factor infertility, eligible for in vitro fertilisation (IVF) and/or
- •intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm
- •from male partner or sperm donor., 5. Infertility for at least one year before
- •randomisation for subjects < 38 years or for at least 6 months for subjects
- •>=38 years (not applicable in case of tubal or severe male factor infertility).
- •, 6. The trial cycle will be the subject*s first controlled ovarian stimulation
- •cycle for IVF/ICSI., 7. Regular menstrual cycles of 24-35 days (both
- •inclusive), presumed to be ovulatory. , 8. Hysterosalpingography,
- •hysteroscopy, saline infusion sonography, or transvaginal ultrasound
- •documenting a uterus consistent with expected normal function (e.g. no evidence
- •of clinically interfering uterine fibroids defined as submucous or intramural
- •fibroids larger than 3 cm in diameter, no polyps and no congenital structural
- •abnormalities which are associated with a reduced chance of pregnancy) within 1
- •year prior to randomisation. , 9. Transvaginal ultrasound documenting presence
- •and adequate visualisation of both ovaries, without evidence of significant
- •abnormality (e.g. no endometrioma greater than 2 cm or enlarged ovaries which
- •would contraindicate the use of gonadotropins) and normal adnexa (e.g. no
- •hydrosalpinx) within 1 year prior to randomisation. Both ovaries must be
- •accessible for oocyte retrieval., 10. Early follicular phase (cycle day 2-5)
- •serum levels of FSH between 1 and 15 IU/L at screening., 11. Negative serum
- •Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human
- •Immunodeficiency Virus (HIV) antibody tests within 1 year prior to
- •randomisation. , 12. Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both
- •inclusive) at screening. , 13. If < 38 years willing to accept single
- •blastocyst transfer. If >=38 years willing to accept transfer of a single
- •good-quality blastocyst (double blastocyst transfer may be performed if no
- •good-quality blastocyst is available).
排除标准
- •1. AMH >35 pmol/L at screening., 2. Strong preference of the subject for either
- •treatment protocol. , 3. Known endometriosis stage III-IV (defined by the
- •revised American Society for Reproductive Medicine [ASRM] classification,
- •1996)., 4. Known history of recurrent miscarriage (defined as three consecutive
- •losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and
- •before week 24 of pregnancy). , 5. Known abnormal karyotype of subject or of
- •her partner / sperm donor, as applicable, depending on source of sperm used for
- •insemination in this trial. , 6. Any known clinically significant systemic
- •disease (e.g. insulin-dependent diabetes)., 7. Known inherited or acquired
- •thrombophilia disease., 8. Active arterial or venous thromboembolism or severe
- •thrombophlebitis, or a history of these events., 9. Known porphyria., 10. Any
- •known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver
- •or kidney) with the exception of controlled thyroid function disease., 11.
- •Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or
- •hypothalamus which would contraindicate the use of gonadotropins., 12. Known
- •moderate or severe impairment of renal or hepatic function., 13. Currently
- •breast-feeding., 14. Undiagnosed vaginal bleeding., 15. Known abnormal cervical
- •cytology of clinical significance observed within 3 years prior to
- •randomisation (unless the clinical significance has been resolved)., 16.
- •Findings at the gynaecological examination at screening which preclude
- •gonadotropin stimulation or are associated with a reduced chance of pregnancy,
- •e.g. congenital uterine abnormalities or retained intrauterine device., 17.
- •Pregnancy (negative pregnancy test must be documented at screening) or
- •contraindication to pregnancy., 18. Known current active pelvic inflammatory
- •disease., 19. Use of fertility modifiers during the last menstrual cycle before
- •randomisation, including dehydroepiandrosterone (DHEA), metformin or cycle
- •programming with oral contraceptives, progestogen or estrogen preparations.,
- •20. Use of hormonal preparations (except for thyroid medication) during the
- •last menstrual cycle before randomisation., 21. Known history of chemotherapy
- •(except for gestational conditions) or radiotherapy. , 22. Current or past (1
- •year prior to randomisation) abuse of alcohol or drugs and/or current (last
- •month) intake of more than 14 units of alcohol per week., 23. Current or past
- •(3 months prior to randomisation) smoking habit of more than 10 cigarettes per
- •day., 24. Hypersensitivity to any active ingredient or excipients in the
- •medicinal products used in the trial., 25. Previous participation in the trial,
- •26. Use of any non-registered investigational drugs during the last 3 months
- •prior to randomisation., See also Withdrawal Criteria in the study protocol.
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