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: 16.1 Level: PT Classification code 10033312 Term: Ovulation induction System Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 16.1 Level: LLT Classification code 10065161 Term: Polycystic ovarian syndrome System Organ Class: 100000004872Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2012-003227-38-GB
- Lead Sponsor
- Merck Serono
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 24
1
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
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.
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