Condition category
Urological and Genital Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Paul Devroey


Contact details

UZ Brussels
Laarbeeklaan 101

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Efficacy, safety and tolerability of XM17 compared to Gonal-f® in women undergoing assisted reproductive technologies: a multinational, multicentre, randomised, controlled, assessor-blind, parallel group phase III study including follow-up periods


Study hypothesis

The primary objective is to show equivalent efficacy of XM17 (human recombinant follicle-stimulating hormone) compared to Gonal-f® in infertile women undergoing assisted reproductive technologies (ART).

Ethics approval

1. Hungary: National Institute of Pharmacy, 18/03/2010, ref: OGYI/684-6/2010
2. Poland: Bioethics Committee of the Regional Medical Council in Bialystok, 17/03/2010, ref: 22/2010/IV
3. Germany: Ethics Committee of the Faculty of Medicine at the University of Heidelberg, 21/04/2010, ref: AFmu-492/2009

Study design

International multicentre prospective randomised controlled assessor-blind parallel-group phase III study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please contact the sponsor below to request a patient information sheet




After checking the suitability of the patient, the patients will be down-regulated with a gonadotropin releasing hormone agonist. After successful down-regulation the patients will be randomised to a treatment with 150 IU/d XM17 (human recombinant FSH) or 150 IU/d Gonal-f® (follitropin alpha). During the first 5 days the dose is fixed to 150 IU/d and thereafter the dose of follicle stimulating hormone (FSH) can be adapted. After successful ovarian stimulation human chorionic gonadotropin will be administered. The cumulus oocyte complexes will be retrieved. Embryo transfer will be performed. A pregnancy test will be done about 16 - 19 days after oocyte retrieval. Clinical pregnancy (foetal heart beat, gestational sacs) will be evaluated by ultrasound examination about 5 - 7 weeks after oocyte retrieval. Patients being pregnant will be followed up until they give birth (follow-up part A). Patients not being pregnant can be treated for a second or third cycle with XM17 as stimulating drug (follow-up part B).

Intervention type



Phase III

Drug names

XM17, Gonal-f®

Primary outcome measure

Number of cumulus oocyte complexes retrieved

Secondary outcome measures

1. Total r-hFSH dose
2. Number of days of r-hFSH stimulation
3. Number of follicles, 17-ß estradiol serum concentration and endometrial thickness on stimulation Day 6 prior to dose adaptation and on the day of hCG injection
4. Cancellation rate
5. Oocyte maturity and quality
6. Fertilisation rate
7. Clinical pregnancy rate

8. Frequency of OHSS
9. Adverse events
10. Vital signs
11. Laboratory tests
12. Physical examination, body weight
13. 12-lead electrocardiogram (ECG)
14. Tolerability (overall and local)
15. Immunogenicity (anti-FSH antibody formation)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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/m^2 inclusive
6. Transvaginal ultrasound documenting the presence of both ovaries without abnormalities and normal adnexa within the last 6 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 6 months prior to study entry
10. Negative pregnancy test prior to starting pituitary downregulation
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

Participant type


Age group




Target number of participants

280 randomised patients (140 per treatment group)

Participant exclusion criteria

1. More than two previously completed consecutive unsuccessful in-vitro fertilisation (IVF) cycles
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 greater than 160 mmHg and diastolic blood pressure greater than 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 radio-therapy
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 3 years), current or past (3 months) smoking habits of greater than 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

Recruitment start date


Recruitment end date



Countries of recruitment

Belgium, Czech Republic, Germany, Hungary, Poland, United Kingdom

Trial participating centre

UZ Brussels

Sponsor information


BioGeneriX AG (Germany)

Sponsor details

Janderstrasse 3
+49 (0)621 8755625

Sponsor type




Funder type


Funder name

BioGeneriX AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2016 results in:

Publication citations

Additional files

Editorial Notes

07/01/2016: Publication reference added.