Efficacy, safety and tolerability of XM17 compared to Gonal-f® in women undergoingassisted reproductive technologies.A multi-national, multi-centre, randomised, controlled, assessor-blind, parallel groupPhase III study including follow-up periods

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 280

Inclusion Criteria

1. Infertile female patients of any racial origin undergoing
superovulation for ART.
2. Aged 18-37 years (inclusive) at the time of enrolment.
3. Good physical and mental health.
4. Regular menstrual cycles of 21-35 days and presumed to be
ovulatory.
5. Body mass index (BMI) between 18-29 kg/m2 inclusive.
6. Transvaginal ultrasound documenting the presence of both
ovaries without abnormalities and normal adnexa within the
last six months.
7. Basal follicle stimulating hormone (FSH), estradiol, prolactin,
thyroid stimulating hormone (TSH) within the normal
reference ranges at enrolment.
8. Normal or clinically insignificant haematology, clinical
chemistry and urinalysis parameters.
9. Negative cervical Pap test within the last six months prior to
study entry.
10. Negative pregnancy test prior to starting pituitary
down-regulation.
11. Able to understand and follow instructions and able to
participate in the study for the entire period.
12. Signed and dated written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. More than two previously completed consecutive unsuccessful
IVF cycles (i.e. completed cycle = oocyte retrieval).
2. Primary ovarian failure or women known as poor responders.
3. More than three miscarriages.
4. History of a severe ovarian hyperstimulation syndrome
(OHSS).
5. Malformations of sexual organs incompatible with pregnancy.
6. One or both ovaries inaccessible for oocyte retrieval.
7. Ovarian enlargement or cyst of more than 2 cm.
8. Hydrosalpinx that has not been surgically removed or ligated.
9. Patient affected by pathologies associated with any
contraindication of being pregnant.
10. Gynaecological haemorrhages of unknown aetiology.
11. Uncontrolled moderate arterial hypertension defined as
systolic blood pressure > 160 mmHg and diastolic blood
pressure > 100 mmHg.
12. Any significant cardiovascular, pulmonary, neurologic,
allergic, endocrine, hepatic, renal or systemic disease.
13. Patient with insulin dependent diabetes mellitus.
14. History of coagulation disorders.
15. Known positive test for human immunodeficiency virus (HIV)
antibodies, hepatitis B or hepatitis C.
16. Neoplasm (e.g. tumours of the ovary, breast, uterus,
hypothalamus or pituitary gland).
17. History of chemo- or radiotherapy.
18. Use of concomitant medications that might interfere with study
evaluations (e.g. prostaglandin inhibitors, psychotropic
agents).
19. Known allergy or hypersensitivity to recombinant FSH
preparations or one of their excipients.
20. History of drug or alcohol abuse (last three years), current or
past (three months) smoking habits of >10 cigarettes per day.
21. Pregnancy or lactation at enrolment.
22. Administration of clomiphene or gonadotropins within 30 days
prior to enrolment.
23. Administration of investigational drugs within 90 days prior to
enrolment.

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

Related Trials