A randomised, controlled, open label, parallel group, multicentre trial comparing the efficacy and safety of individualised FE 999049 (follitropin delta) dosing, using a long GnRH agonist protocol and a GnRH antagonist protocol in women undergoing controlled ovarian stimulatio
- Conditions
- Infertility - Inability to conceive children10013356
- Registration Number
- NL-OMON52678
- Lead Sponsor
- Ferring
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 55
1. Informed Consent Documents signed prior to screening evaluations., 2. In
good physical and mental health. , 3. The subjects must be at least 18 years
(including the 18th birthday) when they sign the informed consent and no more
than 40 years (up to the day before the 41st birthday) at the time of
randomisation., 4. Infertile women diagnosed with tubal infertility,
unexplained infertility, endometriosis stage I/II or with partners diagnosed
with male factor infertility, eligible for in vitro fertilisation (IVF) and/or
intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm
from male partner or sperm donor., 5. Infertility for at least one year before
randomisation for subjects < 38 years or for at least 6 months for subjects
>=38 years (not applicable in case of tubal or severe male factor infertility).
, 6. The trial cycle will be the subject*s first controlled ovarian stimulation
cycle for IVF/ICSI., 7. Regular menstrual cycles of 24-35 days (both
inclusive), presumed to be ovulatory. , 8. Hysterosalpingography,
hysteroscopy, saline infusion sonography, or transvaginal ultrasound
documenting a uterus consistent with expected normal function (e.g. no evidence
of clinically interfering uterine fibroids defined as submucous or intramural
fibroids larger than 3 cm in diameter, no polyps and no congenital structural
abnormalities which are associated with a reduced chance of pregnancy) within 1
year prior to randomisation. , 9. Transvaginal ultrasound documenting presence
and adequate visualisation of both ovaries, without evidence of significant
abnormality (e.g. no endometrioma greater than 2 cm or enlarged ovaries which
would contraindicate the use of gonadotropins) and normal adnexa (e.g. no
hydrosalpinx) within 1 year prior to randomisation. Both ovaries must be
accessible for oocyte retrieval., 10. Early follicular phase (cycle day 2-5)
serum levels of FSH between 1 and 15 IU/L at screening., 11. Negative serum
Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human
Immunodeficiency Virus (HIV) antibody tests within 1 year prior to
randomisation. , 12. Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both
inclusive) at screening. , 13. If < 38 years willing to accept single
blastocyst transfer. If >=38 years willing to accept transfer of a single
good-quality blastocyst (double blastocyst transfer may be performed if no
good-quality blastocyst is available).
1. AMH >35 pmol/L at screening., 2. Strong preference of the subject for either
treatment protocol. , 3. Known endometriosis stage III-IV (defined by the
revised American Society for Reproductive Medicine [ASRM] classification,
1996)., 4. Known history of recurrent miscarriage (defined as three consecutive
losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and
before week 24 of pregnancy). , 5. Known abnormal karyotype of subject or of
her partner / sperm donor, as applicable, depending on source of sperm used for
insemination in this trial. , 6. Any known clinically significant systemic
disease (e.g. insulin-dependent diabetes)., 7. Known inherited or acquired
thrombophilia disease., 8. Active arterial or venous thromboembolism or severe
thrombophlebitis, or a history of these events., 9. Known porphyria., 10. Any
known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver
or kidney) with the exception of controlled thyroid function disease., 11.
Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or
hypothalamus which would contraindicate the use of gonadotropins., 12. Known
moderate or severe impairment of renal or hepatic function., 13. Currently
breast-feeding., 14. Undiagnosed vaginal bleeding., 15. Known abnormal cervical
cytology of clinical significance observed within 3 years prior to
randomisation (unless the clinical significance has been resolved)., 16.
Findings at the gynaecological examination at screening which preclude
gonadotropin stimulation or are associated with a reduced chance of pregnancy,
e.g. congenital uterine abnormalities or retained intrauterine device., 17.
Pregnancy (negative pregnancy test must be documented at screening) or
contraindication to pregnancy., 18. Known current active pelvic inflammatory
disease., 19. Use of fertility modifiers during the last menstrual cycle before
randomisation, including dehydroepiandrosterone (DHEA), metformin or cycle
programming with oral contraceptives, progestogen or estrogen preparations.,
20. Use of hormonal preparations (except for thyroid medication) during the
last menstrual cycle before randomisation., 21. Known history of chemotherapy
(except for gestational conditions) or radiotherapy. , 22. Current or past (1
year prior to randomisation) abuse of alcohol or drugs and/or current (last
month) intake of more than 14 units of alcohol per week., 23. Current or past
(3 months prior to randomisation) smoking habit of more than 10 cigarettes per
day., 24. Hypersensitivity to any active ingredient or excipients in the
medicinal products used in the trial., 25. Previous participation in the trial,
26. Use of any non-registered investigational drugs during the last 3 months
prior to randomisation., See also Withdrawal Criteria in the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br><br /><br>Number of oocytes retrieved</p><br>
- Secondary Outcome Measures
Name Time Method