Condition category
Urological and Genital Diseases
Date applied
09/04/2010
Date assigned
18/05/2010
Last edited
07/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Devroey

ORCID ID

Contact details

UZ Brussels
Laarbeeklaan 101
Brussels
1090
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XM17-05

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Infertility

Intervention

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

Drug

Phase

Phase III

Drug names

XM17, Gonal-f®

Primary outcome measures

Number of cumulus oocyte complexes retrieved

Secondary outcome measures

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)

Overall trial start date

19/03/2010

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Female

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

19/03/2010

Recruitment end date

30/09/2011

Locations

Countries of recruitment

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

Trial participating centre

UZ Brussels
Brussels
1090
Belgium

Sponsor information

Organisation

BioGeneriX AG (Germany)

Sponsor details

Janderstrasse 3
Mannheim
68199
Germany
+49 (0)621 8755625
beate.gertz@biogenerix.com

Sponsor type

Industry

Website

http://www.biogenerix.com

Funders

Funder type

Industry

Funder name

BioGeneriX AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26733057

Publication citations

Additional files

Editorial Notes

07/01/2016: Publication reference added.