CClinicalTrials.gg
Sign In
CompletedNCT01121666Updated Apr 15, 2016Results posted

Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment

A Phase 3 interventional study of Follitropin alfa in Infertility, sponsored by Finox AG. Completed at 16 sites in 6 countries. Open to female participants aged 20 Years to 38 Years. Per ClinicalTrials.gov, last updated 2016-04-15.

Sponsored by Finox AG · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
460
Allocation
Randomized
Ages
20 Years to 38 Years
Sex
Female
01

Study summary

Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.

02

Conditions studied

  • Infertility

Browse trials for

Keywords

  • Assisted reproductive treatment
  • Superovulation
  • Follitropin alfa
  • r-hFSH
  • AFOLIA
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 460 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Finox AG is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 20 and 38 years with regular menstrual cycles of 25-35 days
  • First or second cycle in the present series of ART
  • BMI ≥ 18 ≤ 30 kg/m2
  • Basal FSH \< 10 IU/L (cycle day 2-5)
  • E2 levels \< 50pg/mL (\< 0.18 nmol/L) at the day of FSH administration
  • Antral follicle count (AFC) ≥ 10 to ≤ 25 follicles (sum of both ovaries)
  • Infertility due to any of the following factors: tubal factor, mild endometriosis (ASRM stage 1-2), male factor, unexplained infertility
  • Presence of both ovaries and normal uterine cavity (confirmed by transvaginal ultrasound within 6 months before randomisation)
  • Willingness to participate in the study and to comply with the study protocol
  • Informed consent

Exclusion criteria

Exclusion Criteria:

  • Presence of pregnancy
  • History of ≥2 succeeding ART cycles (IVF and/or ICSI) before the study cycle without clinical pregnancy
  • Presence of clinically significant systemic disease
  • Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
  • Presence of uncontrolled endocrine disorder
  • Previous history or presence of severe ovarian hyperstimulation syndrome
  • Presence of polycystic ovaries (PCO)
  • Presence of severe endometriosis (ASRM stage 3 or stage 4) and hydrosalpinx
  • Neoplasia, including tumors of the hypothalamus and pituitary gland
  • Abnormal bleeding of undetermined origin
  • History of poor response to gonadotropin treatment (defined as fewer than 5 oocytes retrieved in a previous attempt)
  • Male infertility without mobile spermatozoa in the ejaculate, that need testicular of epididymal sperm retrieval (MESA/TESE/TESA)
  • Endocrine abnormality such as TSH or prolactin level elevations outside the reference range if clinically relevant at screening
  • Any hormonal treatment within 1 month before the start of the FSH treatment (with the exception of levothyroxin)
  • History of drug, nicotine or alcohol abuse within the last 12 months (> 10 cigarettes/day)
  • Administration of other investigational products within the last month
  • Clinically abnormal findings at Visit 1
  • Planned PGS/PGD/PBB or assisted hatching
  • Concomitant participation in an other study protocol
  • History of extrauterine pregnancy in the previous 3 months
  • Known allergy or hypersensitivity to progesterone or to any of the excipients (including peanut oil) of the additional study medication (GnRH agonist, vitrelle®, and Utrogestan®)
  • Presence or history of thrombophlebitis or thromboembolic disorders
  • Presence or history of cerebral haemorrhage
  • Presence or history of porphyria
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
460 participants (actual)

Study arms

  • Active comparator
    Gonal-f® (Follitropin alfa)

    Drug: Follitropin alfa

  • Experimental
    AFOLIA-150 (Follitropin alfa)

    Drug: Follitropin alfa

Interventions

  • DrugFollitropin alfa

    150IU per day subcutaneously for a maximum of 16 days

06

What researchers measure

Primary outcomes

  1. Number of Oocytes Retrieved (Per Protocol Population)

    As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes

    Time frame: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment

  2. Number of Oocytes Retrieved (Intention-to-treat Population)

    As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes

    Time frame: 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment

Secondary outcomes

  1. Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation

    The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.

    Time frame: Day 8 of stimulation

  2. E2 Concentration at Day 8 and at Day of hCG Administration

    The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.

    Time frame: Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)

  3. Total Dose of r-hFSH Administered

    Total dose of r-hFSH required was assessed.

    Time frame: Day of hCG administration (after maximum 16 days of r-hFSH treatment)

  4. Quality of Oocytes Retrieved

    Number of patients with ovum pick-up

    Time frame: 34-36 hours after hCG administration

  5. Fertilisation Rate of Oocytes

    Fertilisation rate was assessed

    Time frame: 1 day after ovum pick-up

  6. Embryo Quality: Mean Number of Blastomeres

    Main embryo quality parameter "mean number of blastomeres"

    Time frame: Day 2 of OPU/fertilisation

  7. Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts

    Time frame: Day 1, 2, 3 and 5 of OPU/fertilisation

  8. Number of Days of r-hFSH Stimulation

    Mean duration of stimulation was assessed.

    Time frame: At the day of hCG administration, up to 16 days

  9. Number of Patients With Cycle Cancellation

    Number of patients with cycle cancellation was assessed.

    Time frame: Until child birth/miscarriage, up to the end of the study

  10. Number of Patients With Good Response

    Good response was defined as "patients with an oocyte retrieval of four or more oocytes"

    Time frame: Until child birth/miscarriage, up to the end of the study

  11. Implantation Rate

    Defined as fetal sac per embryo transferred.

    Time frame: Five to six weeks after oocyte retrieval

  12. Clinical Pregnancy Rate

    Presence of at least one intrauterine gestational sac.

    Time frame: Five to six weeks after oocyte retrieval

  13. Ongoing Pregnancy

    Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.

    Time frame: Ten weeks after embryo transfer

  14. Live Birth Rate

    Patients with liveborn children

    Time frame: After childbirth with questionnaire

  15. Embryo Quality: Absence of Multinucleation

    Main embryo quality parameter "absence of multinucleation" observed.

    Time frame: Day 3

  16. Quality of Oocytes Retrieved

    Number of patients with transferred blastocysts

    Time frame: At day 4 and 5

  17. Quality of Oocytes Retrieved

    Number of embryos per blastocysts transferred

    Time frame: Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval

  18. Clinical Pregnancy Rate (Second Treatment Cycle)

    Presence of at least one intrauterine gestational sac.

    Time frame: Five to six weeks after oocyte retrieval

  19. Ongoing Pregnancy (Second Treatment Cycle)

    Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.

    Time frame: 10 weeks after embryo transfer

  20. Quality of Oocytes Retrieved

    The maturity of the cumulus oophorus was assessed.

    Time frame: After oocyte retrieval, 34 to 36 hours after hCG administration

  21. Quality of Oocytes Retrieved

    The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).

    Time frame: After oocyte retrieval, 34 to 36 hours after hCG administration

07

Results

Posted Apr 15, 2016

Participant flow

Subjects were screened and enrolled at 15 centers in six European countries from July 2010 until April 2012.

Participant flow — Overall Study
MilestoneAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Started249123
Completed220113
Not completed2910
Withdrew: Protocol violation2910

Outcome measures

PrimaryNumber of Oocytes Retrieved (Per Protocol Population)

As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes

Time frame:
34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment
Reported as:
Mean · Number of retrieved oocytes
Number of Oocytes Retrieved (Per Protocol Population)
Number of retrieved oocytesAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Number of Oocytes Retrieved (Per Protocol Population)10.8 ± 5.1110.6 ± 6.06
Statistical analysis
  • AFOLIA-150 (Follitropin Alfa) vs Gonal-f® (Follitropin Alfa) · Shuirmann's TOST · p = 0.0003 (This study was powered to test equivalence using a two one-sided test (TOST) with a power of 90%, an alpha error of 2.5% and a pre-determined clinical equivalence margin of +/-2.9 oocytes for the relevant population.)
SecondaryNumber and Size of Follicles ≥ 12 mm at Day 8 of Stimulation

The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point.

Time frame:
Day 8 of stimulation
Reported as:
Mean · Number of follicles
Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation
Number of folliclesAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
≥ 12 mm11.8 ± 4.7311.1 ± 4.23
≥ 15 mm8.3 ± 3.817.7 ± 3.60
≥ 17 mm4.9 ± 3.294.5 ± 2.71
Statistical analysis
  • AFOLIA-150 (Follitropin Alfa) vs Gonal-f® (Follitropin Alfa) · Wilcoxon (Mann-Whitney) · p = 0.2357 (Follicles of 12 mm)
  • AFOLIA-150 (Follitropin Alfa) vs Gonal-f® (Follitropin Alfa) · Wilcoxon (Mann-Whitney) · p = 0.1395 (Follicles of 15 mm)
  • AFOLIA-150 (Follitropin Alfa) vs Gonal-f® (Follitropin Alfa) · Wilcoxon (Mann-Whitney) · p = 0.3992 (Follicles of 17 mm)
SecondaryE2 Concentration at Day 8 and at Day of hCG Administration

The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration.

Time frame:
Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment)
Reported as:
Mean · pmol/ L
E2 Concentration at Day 8 and at Day of hCG Administration
pmol/ LAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Day of hCG administration8982.3 ± 6535.37704.2 ± 5345.8
Day 83958.9 ± 3699.43234.0 ± 2428.1
SecondaryTotal Dose of r-hFSH Administered

Total dose of r-hFSH required was assessed.

Time frame:
Day of hCG administration (after maximum 16 days of r-hFSH treatment)
Reported as:
Mean · IU
Total Dose of r-hFSH Administered
IUAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Total Dose of r-hFSH Administered1555.7 ± 293.001569.2 ± 259.20
Statistical analysis
  • AFOLIA-150 (Follitropin Alfa) vs Gonal-f® (Follitropin Alfa) · Wilcoxon (Mann-Whitney) · p = 0.9638
SecondaryQuality of Oocytes Retrieved

Number of patients with ovum pick-up

Time frame:
34-36 hours after hCG administration
Reported as:
Number · Participants
Quality of Oocytes Retrieved
ParticipantsAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
day 28236
day 35328
SecondaryFertilisation Rate of Oocytes

Fertilisation rate was assessed

Time frame:
1 day after ovum pick-up
Reported as:
Mean · percentage of oocytes
Fertilisation Rate of Oocytes
percentage of oocytesAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Fertilisation Rate of Oocytes66.1 ± 24.8464.0 ± 24.76
SecondaryEmbryo Quality: Mean Number of Blastomeres

Main embryo quality parameter "mean number of blastomeres"

Time frame:
Day 2 of OPU/fertilisation
Reported as:
Mean · Number of blastomeres at day 3
Embryo Quality: Mean Number of Blastomeres
Number of blastomeres at day 3AFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Embryo Quality: Mean Number of Blastomeres6.6 ± 2.416.4 ± 2.49
SecondaryNumber of Participants With Cryopreserved 2PNs, Embryos/Blastocysts
Time frame:
Day 1, 2, 3 and 5 of OPU/fertilisation
Reported as:
Number · Patients with cryopreservation
Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts
Patients with cryopreservationAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts10355
SecondaryNumber of Days of r-hFSH Stimulation

Mean duration of stimulation was assessed.

Time frame:
At the day of hCG administration, up to 16 days
Reported as:
Mean · days
Number of Days of r-hFSH Stimulation
daysAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Number of Days of r-hFSH Stimulation10.6 ± 1.9110.7 ± 1.72
Statistical analysis
  • AFOLIA-150 (Follitropin Alfa) vs Gonal-f® (Follitropin Alfa) · Wilcoxon (Mann-Whitney) · p = 0.8926
SecondaryNumber of Patients With Cycle Cancellation

Number of patients with cycle cancellation was assessed.

Time frame:
Until child birth/miscarriage, up to the end of the study
Reported as:
Number · Number of patients
Number of Patients With Cycle Cancellation
Number of patientsAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Number of Patients With Cycle Cancellation135
SecondaryNumber of Patients With Good Response

Good response was defined as "patients with an oocyte retrieval of four or more oocytes"

Time frame:
Until child birth/miscarriage, up to the end of the study
Reported as:
Number · Participants
Number of Patients With Good Response
ParticipantsAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Number of Patients With Good Response217107
SecondaryImplantation Rate

Defined as fetal sac per embryo transferred.

Time frame:
Five to six weeks after oocyte retrieval
Reported as:
Number · Percentage of implantations
Implantation Rate
Percentage of implantationsAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Implantation Rate31.836.7
SecondaryClinical Pregnancy Rate

Presence of at least one intrauterine gestational sac.

Time frame:
Five to six weeks after oocyte retrieval
Reported as:
Number · Clinical pregnancies
Clinical Pregnancy Rate
Clinical pregnanciesAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Clinical Pregnancy Rate9055
SecondaryOngoing Pregnancy

Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.

Time frame:
Ten weeks after embryo transfer
Reported as:
Number · Ongoing pregnancies
Ongoing Pregnancy
Ongoing pregnanciesAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Ongoing Pregnancy8451
SecondaryLive Birth Rate

Patients with liveborn children

Time frame:
After childbirth with questionnaire
Reported as:
Number · Patients with liveborn children
Live Birth Rate
Patients with liveborn childrenAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Live Birth Rate8051
PrimaryNumber of Oocytes Retrieved (Intention-to-treat Population)

As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes

Time frame:
34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment
Reported as:
Mean · Number of retrieved oocytes
Number of Oocytes Retrieved (Intention-to-treat Population)
Number of retrieved oocytesAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Number of Oocytes Retrieved (Intention-to-treat Population)10.7 ± 5.6210.4 ± 6.14
Statistical analysis
  • AFOLIA-150 (Follitropin Alfa) vs Gonal-f® (Follitropin Alfa) · Shuirmann's TOST · p = 0.0003
SecondaryEmbryo Quality: Absence of Multinucleation

Main embryo quality parameter "absence of multinucleation" observed.

Time frame:
Day 3
Reported as:
Number · Percentage of absent multinucleation
Embryo Quality: Absence of Multinucleation
Percentage of absent multinucleationAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Embryo Quality: Absence of Multinucleation93.693.9
SecondaryQuality of Oocytes Retrieved

Number of patients with transferred blastocysts

Time frame:
At day 4 and 5
Reported as:
Number · Participants
Quality of Oocytes Retrieved
ParticipantsAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
day 4102
day 57646
SecondaryQuality of Oocytes Retrieved

Number of embryos per blastocysts transferred

Time frame:
Day of embryo transfer, either 2, 3 or 5 days after oocyte retrieval
Reported as:
Mean · embryos per blastocysts transferred
Quality of Oocytes Retrieved
embryos per blastocysts transferredAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Quality of Oocytes Retrieved1.5 ± 0.521.6 ± 0.53
SecondaryClinical Pregnancy Rate (Second Treatment Cycle)

Presence of at least one intrauterine gestational sac.

Time frame:
Five to six weeks after oocyte retrieval
Reported as:
Number · Clinical pregnancies
Clinical Pregnancy Rate (Second Treatment Cycle)
Clinical pregnanciesAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Clinical Pregnancy Rate (Second Treatment Cycle)2510
SecondaryOngoing Pregnancy (Second Treatment Cycle)

Ongoing pregnancy per embryo transfer. Presence of at least one viable fetus 10 weeks after embryo transfer.

Time frame:
10 weeks after embryo transfer
Reported as:
Number · Ongoing pregnancies
Ongoing Pregnancy (Second Treatment Cycle)
Ongoing pregnanciesAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Ongoing Pregnancy (Second Treatment Cycle)229
SecondaryQuality of Oocytes Retrieved

The maturity of the cumulus oophorus was assessed.

Time frame:
After oocyte retrieval, 34 to 36 hours after hCG administration
Reported as:
Number · Percentage of cumulus oophori
Quality of Oocytes Retrieved
Percentage of cumulus oophoriAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
very mature9.19.4
mature75.775.3
immature14.514.2
SecondaryQuality of Oocytes Retrieved

The nuclear maturity was assessed (Germinal vesicle, Metaphase I, Metaphase II).

Time frame:
After oocyte retrieval, 34 to 36 hours after hCG administration
Reported as:
Number · Percentage of cells
Quality of Oocytes Retrieved
Percentage of cellsAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Germinal vesicle9.59.1
Metaphase I7.27.7
Metaphase II83.483.3

Adverse events

Collected over Study period + 30 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AFOLIA-150 (Follitropin Alfa)—12/249 (4.8%)182/249 (73.1%)
Gonal-f® (Follitropin Alfa)—3/123 (2.4%)83/123 (67.5%)
Most frequent serious events
Most frequent serious events
EventAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Ovarian hyperstimulation syndromeReproductive system and breast disorders7/2492/123
SyncopeNervous system disorders0/2491/123
Abdominal painGastrointestinal disorders2/2490/123
Biliary colicHepatobiliary disorders1/2490/123
Ovarian haemorrhageReproductive system and breast disorders1/2490/123
Body temparature increasedInvestigations1/2490/123
Most frequent other events
Showing 10 of 11
Most frequent other events
EventAFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)
Injection site erythemaGeneral disorders68/24944/123
Injection site haematomaGeneral disorders60/24919/123
HeadacheNervous system disorders55/24925/123
Ovarian hyperstimulation syndromeReproductive system and breast disorders55/24916/123
Injection site painGeneral disorders39/24921/123
NauseaGastrointestinal disorders23/2496/123
Injection site swellingGeneral disorders15/24910/123
Abdominal pain upperGastrointestinal disorders7/2497/123
Abdominal distensionGastrointestinal disorders14/2496/123
FatigueGeneral disorders13/2494/123

Baseline characteristics

Age, Continuous
Age, Continuous(years)AFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)Total
Mean31.8 ± 4.0232.1 ± 3.7631.95 ± 3.90
Sex: Female, Male
Sex: Female, Male(Participants)AFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)Total
Female249123372
Male000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)Total
American Indian or Alaska Native000
Asian12315
Native Hawaiian or Other Pacific Islander000
Black or African American213
White229117346
More than one race000
Unknown or Not Reported628
Region of Enrollment
Region of Enrollment(participants)AFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)Total
Austria8843131
Denmark7537112
Spain331952
Germany241135
United Kingdom211031
Switzerland8311
FSH baseline concentration
FSH baseline concentration((IU/L))AFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)Total
Mean6.9 (2.5 to 17.1)6.9 (2.8 to 10)6.9 (2.5 to 17.1)
Antral follicle count
Antral follicle count(Antral follicle count)AFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)Total
Mean15.1 (10 to 24)15.3 (10 to 24)15.2 (10 to 24)
Body Mass Index
Body Mass Index(kilogramm/ square meter)AFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)Total
Mean22.7 (18.0 to 30.3)22.4 (18.2 to 28.7)22.6 (18.0 to 30.3)
GnRH-agonist duration
GnRH-agonist duration(days)AFOLIA-150 (Follitropin Alfa)Gonal-f® (Follitropin Alfa)Total
Mean23.5 (11.0 to 44.0)22.7 (12.0 to 46.0)23.1 (11.0 to 46.0)

1 further baseline measures are reported on the registry.

08

Study locations

16 sites
  • Kinderwunsch Institut Schenk GmbH
    Graz, Austria
  • Landes-Frauenklinik und Kinderklinik Linz
    Linz, Austria
  • AKH Vienna
    Vienna, 1090, Austria
  • IVF Zentrum Döbling
    Vienna, 11920, Austria
  • Privatspital Goldenes Kreuz
    Wien, Austria
  • Fertility Clinic
    Copenhagen, 2100, Denmark
  • Copenhagen Fertility Center
    Copenhagen, 2400, Denmark
  • Dansk Fertilitetsklinik
    Frederiksberg, 2000, Denmark
  • Universitätsklinikum Bonn
    Bonn, 53105, Germany
  • Universitäts-Frauenklinik
    Heidelberg, Germany
  • Institut Universitari Dexeus
    Barcelona, 08028, Spain
  • IVI Madrid
    Madrid, 28023, Spain
  • University Hospital of Zurich
    Zurich, 8091, Switzerland
  • Guy's and St Thomas' NHS Foundation Trust
    London, SE1 9RT, United Kingdom
  • Kings College Hospital
    London, United Kingdom
  • St Barthlomew's Hospital
    London, United Kingdom
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01121666
Lead sponsor
Finox AG
Responsible party
Sponsor
First posted
May 12, 2010
Start date
Jun 2010
Primary completion
Dec 2011
Completion
Mar 2013
Results posted
Apr 15, 2016
Last update
Apr 15, 2016

Study contacts

Bruno Imthurn
principal investigator · University of Zurich

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infertility→

Other studies from this sponsor

Finox AG

Start the discussion