EUCTR2012-003227-38-GB进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck Serono
- 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
入选标准
- •To be eligible for inclusion into this trial, the subjects must fulfill all the following criteria:
- •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. Patients who did not conceive after clomifene therapy, even if the therapy resulted in follicular development, are eligible for inclusion in the study. Those patients who did conceive after clomifene treatment and then had a subsequent miscarriage are not eligible for the study. Any miscarriages that occurred separately to their treatment with clomifene do not make the patient ineligible as long as they have had less than 3 miscarriages and have also failed treatment with clomifene (as described above).
- •6.Subjects with FSH serum values within the normal range in the early follicular phase.
- •7.Subjects with an overall total antral follicle count (AFC) >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), hysterosalpingo contrast sonography (HyCoSy) or laparoscopy.
- •9.Subjects with normal uterine cavity, as documented by recent (within 2 years before treatment assignment) hysteroscopy, HSG, ultrasound scan or laparoscopy.
- •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 fertilisation 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 116
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Exclusion criteria
- •To be eligible for inclusion in this trial the subjects must not meet any of the following criteria:
- •1.Subjects with history of hypersensitivity to the investigational medicinal product (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 polycystic ovary syndrome (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 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 ovarian hyperstimulation syndrome (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 clinically significant abnormal prolactin (PRL) serum values in the early follicular phase.
- •17.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.
- •18.An active substance abuser.
- •19.Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner.
- •20.Subjects who are currently participating in another clinical trial.
- •21.Subjects who are unable to give written informed consent.
研究者
相似试验
进行中（未招募）
不适用
A study to assess two treatment regimes of injectable hormones, Gonadotrophins, which are used to treat fertility problems in women, in the effectiveness of inducing egg stimulation in women who are unable to ovulate by themselves.Anovulation in women with PCOSMedDRA version: 14.1Level: PTClassification code 10033312Term: Ovulation inductionSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 14.1Level: LLTClassification code 10065161Term: Polycystic ovarian syndromeSystem Organ Class: 100000004872EUCTR2012-003227-38-IEMerck Serono Ltd94
进行中（未招募）
不适用
Experimental clinical trial regarding relapsing-remitTing Multiple Sclerosis newly diagnosed patients, not yet treated for the evaluation of the onset, the efficacy and speed of action of the treatment with BG00012EUCTR2015-000303-21-ITBiogen Idec Italia S.r.l.
进行中（未招募）
1 期
Evaluation of a Treat and Extend regimen of intravitreal aflibercept for macular edema secondary to CRVOMacular edema secondary to CRVOMedDRA version: 19.1 Level: PT Classification code 10025415 Term: Macular oedema System Organ Class: 10015919 - Eye disordersEUCTR2014-003193-17-DKBayer AG160
进行中（未招募）
1 期
Evaluation of a Treat and Extend regimen of intravitreal aflibercept for macular edema secondary to CRVOEUCTR2014-003193-17-GBBayer AG160
进行中（未招募）
1 期
Evaluation of a Treat and Extend regimen of intravitreal aflibercept for macular edema secondary to CRVOEUCTR2014-003193-17-ITBAYER AG162