Efficacy, safety and tolerability of XM17 compared to Gonal-f® in women undergoing assisted reproductive technologies

ISRCTN ISRCTN74772901
DOI https://doi.org/10.1186/ISRCTN74772901
Protocol serial number XM17-05
Sponsor BioGeneriX AG (Germany)
Funder BioGeneriX AG (Germany)
Submission date
09/04/2010
Registration date
18/05/2010
Last edited
07/01/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul Devroey
Scientific

UZ Brussels
Laarbeeklaan 101
Brussels
1090
Belgium

Study information

Primary study designInterventional
Study designInternational multicentre prospective randomised controlled assessor-blind parallel-group phase III study
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleEfficacy, 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 objectivesThe 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(s)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
Health condition(s) or problem(s) studiedInfertility
InterventionAfter 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 typeDrug
PhasePhase III
Drug / device / biological / vaccine name(s)XM17, Gonal-f®
Primary outcome measure(s)

Number of cumulus oocyte complexes retrieved

Key secondary outcome measure(s)

Efficacy:
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

Safety:
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)

Completion date30/09/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target sample size at registration280
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment19/03/2010
Date of final enrolment30/09/2011

Locations

Countries of recruitment

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

Study participating centre

UZ Brussels
Brussels
1090
Belgium

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 06/01/2016 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

07/01/2016: Publication reference added.

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