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.
- Conditions
- 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: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2012-003227-38-IE
- Lead Sponsor
- Merck Serono Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 94
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method