Trial Outcomes & Findings for FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST) (NCT NCT01969201)

NCT ID: NCT01969201

Last Updated: 2019-10-09

Results Overview

A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 710 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2019-10-09

Participant Flow

Participant milestones

Measure	Fostimon® 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha
Overall Study STARTED	352	358
Overall Study COMPLETED	307	313
Overall Study NOT COMPLETED	45	45

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)

Baseline characteristics by cohort

Measure	Fostimon® n=352 Participants 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® n=358 Participants 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha	Total n=710 Participants Total of all reporting groups
Age, Continuous	32.39 years STANDARD_DEVIATION 3.83 • n=5 Participants	32.68 years STANDARD_DEVIATION 3.52 • n=7 Participants	32.53 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	352 Participants n=5 Participants	358 Participants n=7 Participants	710 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	336 Participants n=5 Participants	339 Participants n=7 Participants	675 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Turkey	55 participants n=5 Participants	59 participants n=7 Participants	114 participants n=5 Participants
Region of Enrollment Belgium	39 participants n=5 Participants	41 participants n=7 Participants	80 participants n=5 Participants
Region of Enrollment United Kingdom	44 participants n=5 Participants	44 participants n=7 Participants	88 participants n=5 Participants
Region of Enrollment Italy	91 participants n=5 Participants	88 participants n=7 Participants	179 participants n=5 Participants
Region of Enrollment Switzerland	24 participants n=5 Participants	25 participants n=7 Participants	49 participants n=5 Participants
Region of Enrollment Spain	99 participants n=5 Participants	101 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;

Outcome measures

Measure	Fostimon® n=352 Participants 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® n=358 Participants 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha
Clinical Pregnancy Rate	36.93 percentage of participants	39.66 percentage of participants

SECONDARY outcome

Timeframe: 10-15 days after starting FSH stimulation

Population: Subject with available data.

Outcome measures

Measure	Fostimon® n=347 Participants 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® n=350 Participants 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha
Number of Follicles >16 mm on the Day of hCG Injection	4.10 follicles >16 mm Standard Deviation 2.47	4.47 follicles >16 mm Standard Deviation 2.33

SECONDARY outcome

Timeframe: end of treatment period, approximately 2 - 3 weeks.

Population: subjects who underwent oocytes retrieval

Outcome measures

Measure	Fostimon® n=337 Participants 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® n=346 Participants 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha
Total Number of Oocytes Retrieved	8.45 oocytes Standard Deviation 4.72	9.33 oocytes Standard Deviation 4.90

SECONDARY outcome

Timeframe: end of treatment period, approximately 2 - 3 weeks

Population: subjects with at least one oocyte inseminated.

Outcome measures

Measure	Fostimon® n=331 Participants 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® n=338 Participants 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha
Fertilization Rate	73.98 percentage of oocytes Standard Deviation 26.44	75.85 percentage of oocytes Standard Deviation 21.48

SECONDARY outcome

Timeframe: On culture day 3

Population: Subject with at least one embryo transferred, with embryo scoring available.

The embryo quality evaluation will be performed on culture day 3, just before embryo transfer and will consist in the assessment of blastomeres number and 2 embryo morphology parameters: degree of fragmentation and cell division aspect.

Outcome measures

Measure	Fostimon® n=304 Participants 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® n=314 Participants 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha
Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)	0.47 Top embryos Standard Deviation 0.64	0.48 Top embryos Standard Deviation 0.64

SECONDARY outcome

Timeframe: 2 weeks after embryo transfer

Two weeks after embryo transfer, a serum pregnancy test will be performed.

Outcome measures

Measure	Fostimon® n=352 Participants 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® n=358 Participants 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha
Positive Serum Pregnancy Test Rate	47.2 percentage of participants	49.7 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: For 4 patients, 3 allocated to the Fostimon® group and 1 allocated to the Gonal-F® group this information was not available because of lost to follow-up.

Outcome measures

Measure	Fostimon® n=349 Participants 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® n=357 Participants 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha
Delivery Rate	34.4 percentage of participants	36.7 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Patients who will not get pregnant during the study, will be allowed to perform a frozen embryo transfer. Cumulative pregnancy rate will include also pregnancies achieved after a frozen embryo transfer.

Outcome measures

Measure	Fostimon® n=352 Participants 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® n=358 Participants 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha
Cumulative Pregnancy Rate	45.2 percentage of participants	52.0 percentage of participants

Adverse Events

Fostimon®

Serious events: 24 serious events

Other events: 36 other events

Deaths: 0 deaths

Gonal-F®

Serious events: 31 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fostimon® n=352 participants at risk 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® n=358 participants at risk 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Surgical and medical procedures Abortion induced	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.00% 0/358 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Nervous system disorders seizure	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Abortion early	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Abortion incomplete	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions abortion missed	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.00% 0/358 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions abortion spontaneous	0.85% 3/352 • Number of events 3 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.84% 3/358 • Number of events 3 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Cervical incompetence	0.57% 2/352 • Number of events 2 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.00% 0/358 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions ectopic pregnancy	0.85% 3/352 • Number of events 3 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions gestational diabetes	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.56% 2/358 • Number of events 2 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions imminent abortion	0.57% 2/352 • Number of events 2 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.56% 2/358 • Number of events 2 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Multiple pregnancy	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Oligohydramniosis	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Placenta praevia haemorrage	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Postpartum haemorrage	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.56% 2/358 • Number of events 2 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions premature delivery	0.85% 3/352 • Number of events 3 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	2.0% 7/358 • Number of events 7 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions premature labour	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions premature rupture of membranes	0.57% 2/352 • Number of events 2 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.00% 0/358 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Threatened labour	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.56% 2/358 • Number of events 2 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Vomiting in pregnancy	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.00% 0/358 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Gastrointestinal disorders abdominal pain lower	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.00% 0/358 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Gastrointestinal disorders intra abdominal haemorrage	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Gastrointestinal disorders peritoneal haemorrage	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Reproductive system and breast disorders Adnexal torsion	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Reproductive system and breast disorders Ovarian cyst	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.00% 0/358 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Reproductive system and breast disorders Ovarian hyperstimulation syndrome	0.57% 2/352 • Number of events 2 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	1.1% 4/358 • Number of events 4 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Reproductive system and breast disorders pelvic pain	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.00% 0/358 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Reproductive system and breast disorders Uterine polyp	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.00% 0/358 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Reproductive system and breast disorders Vaginal haemorrage	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.56% 2/358 • Number of events 2 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/352 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.28% 1/358 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Infections and infestations infection	0.28% 1/352 • Number of events 1 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	0.00% 0/358 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).

Other adverse events

Measure	Fostimon® n=352 participants at risk 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin	Gonal-F® n=358 participants at risk 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha
Injury, poisoning and procedural complications Procedural pain	2.0% 7/352 • Number of events 7 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	2.2% 8/358 • Number of events 8 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Nervous system disorders Headache	2.0% 7/352 • Number of events 7 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	3.1% 11/358 • Number of events 15 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	4.3% 15/352 • Number of events 15 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	4.2% 15/358 • Number of events 15 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
Reproductive system and breast disorders Vaginal haemorrage	2.0% 7/352 • Number of events 8 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).	2.2% 8/358 • Number of events 8 • Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).

Additional Information

Project Leader

IBSA Insitut Biochimique

Phone: +41 58 360 10 00

Email: rd@ibsa.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place