EUCTR2012-003227-38-IE进行中（未招募）不适用
A Multi-Centre, Two-Arm, Interventional, Phase IV Study to Evaluate Tailoring of Recombinant FSH Treatment in Subjects with Chronic Anovulation Using the Gonal-f® Prefilled Pen in Women Undergoing Ovulation Induction - Low Dose Gonal-f in Ovulation Induction (LoGo)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 94
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.Subjects eligible for ovulation induction treatment, where monofollicular development is the desired treatment outcome and the dose schedule outlined in the protocol is deemed appropriate
- •2.Premenopausal female subjects, aged between 18 and 37 years inclusive
- •3.Subjects desirous of pregnancy / willing to conceive
- •4.Subjects who are infertile due to chronic anovulation demonstrated by a cycle duration of > 35 days.
- •5.Subjects who have been treated with clomifene citrate therapy, according to standard site practice, and have failed to ovulate and/or conceive
- •6.Subjects with FSH and PRL serum values within the normal range in the early follicular phase
- •7.Subjects with an overall total antral follicle count > 10 (of follicle size = 2 mm and < 11 mm) (i.e. total between both ovaries)
- •8.Subjects with at least one patent tube, as documented by recent (within 2 years before treatment assignment) hysterosalpingography (HSG) or hysterosalpingo contrast sonography (HyCoSy)
- •9.Subjects with normal uterine cavity, as documented by recent (within 2 years before treatment assignment) hysteroscopy, HSG or ultrasound scan
- •10.Subjects with body mass index (BMI) >20 and =32 kg/m2
- •11.Subjects with negative cervical Papanicolaou (PAP) test conducted according to national guidelines and/or standard site practice.
- •12.Male partners of female subjects with sperm compatible with non-assisted fertilization or availablility of donor sperm, as confirmed by the Investigator.
- •13.Subjects who are willing and able to comply with protocol requirements and have provided written, informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 94
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Subjects with history of hypersensitivity to the IMP (active substance follitropin alpha, FSH, or to any of the excipients of Gonal-f) or any other drug used in the trial (i.e. Ovitrelle)
- •2.Subjects with ovarian enlargement or ovarian cyst unrelated to PCOS, and of unknown origin on ultrasound
- •3.Subjects with evidence of diminished ovarian reserve (cycle length < 26 days; FSH above the upper limit of local serum FSH values, total antral follicle count (AFC) in both ovaries < 10)
- •4.Subjects with uterine pathology/abnormalities, which in the opinion of the investigator could impair pregnancy evolution
- •5.Subjects who have undergone three or more previous miscarriages
- •6.Subjects with any previous extrauterine pregnancy
- •7.Pregnant or lactating female subjects
- •8.Subjects with abnormal gynaecological bleeding of unknown aetiology.
- •9.Subjects with previous history of severe OHSS (after clomifene treatment)
- •10.Subjects who have evidence of current or previous pelvic inflammatory disease before treatment assignment
- •11.Subjects with tumours of the hypothalamus and pituitary gland
- •12.Subjects with ovarian, uterine or mammary carcinoma
- •13.Subjects treated with clomifene citrate or gonadotropins within 1 month of the screening evaluation
- •14.Subjects with any medical condition which, in the opinion of the investigator, would prevent an effective response, such as primary ovarian failure, or malformations of the reproductive organs incompatible with pregnancy
- •15.Subjects with any medical condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug
- •16.Subjects with any clinically significant systemic disease (e.g. insulin-dependent diabetes) or any contraindication to being pregnant and/or carrying a pregnancy to term
- •17.An active substance abuser
- •18.Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner
- •19.Subjects who are currently participating in another clinical trial
- •20.Subjects who are unable to give written informed consent
研究者
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