Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients

Safety and Efficacy Study Comparing a New hMG Formulation (hMG-IBSA) to a Reference Product (Menopur®) in Patients Undergoing Ovarian Stimulation for in Vitro Fertilisation (IVF)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01312766

Enrollment

270

Registered

2011-03-11

Start date

2011-02-28

Completion date

2013-12-31

Last updated

2016-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.

Interventions

DRUGMenotropins

Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Women undergoing ovarian stimulation for IVF with the following characteristics: * Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule * \>18 and \<40 years old * BMI between 18 and 30 kg/m2 * less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery) * basal FSH \<10 IU/L and E2 \<80 pg/ml (\ 290 pmol/l) * Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination * Successful down-regulation performed with a standard GnRH-Agonist long protocol (Criteria for successful down-regulation: endometrial thickness \< 7mm or serum E2 level \<50 pg/ml (\ 185 pmol/l).

Exclusion criteria

* age \<18 and \>40 years * primary ovarian failure or women known as poor responders (i.e. requiring more than 225 IU of hMG as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with a pre-ovulatory E2 serum concentration \<500pg/ml (\ 1800 pmol/l)) * PCOS * one or both ovaries inaccessible for oocyte retrieval * ovarian cysts \>10 mm * hydrosalpinx that have not been surgically removed or ligated; * stage 3 or 4 endometriosis * oocyte donation * implantation of previously frozen embryos * patients affected by pathologies associated with any contraindication of being pregnant * hypersensitivity to the study medication * abnormal bleeding of undetermined origin * uncontrolled thyroid or adrenal dysfunction * neoplasias * severe impairment of renal and/or hepatic function * use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents)

Design outcomes

Primary

Measure	Time frame
Total Number of Oocytes Retrieved	up to 24 days after treatment start

Secondary

Measure	Time frame	Description
Total Number of Inseminated Oocytes (IVF and ICSI)	on the day of oocyte retrieval	number of oocytes that were inseminated via IVF or injected via ICSI technique.
Number of Cleaved Embryos	two days after insemination	—
Live Birth Rate	9 months after treatment	—
Mean hMG Dose (Total);	up to 22 days after treatment start	—
Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)	up to 28 days after treatment start	Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.
Ratio Mature/Total Number of Oocytes Retrieved.	at the end of the stimulation.	Percentage of retrieved oocytes considered to be mature.
Controlled Ovarian Stimulation Duration (Days)	up to 23 days after treatment start	—
17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;	up to 23 days after treatment start	—
Implantation Rate	10-11 weeks after embryo transfer	defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;
Clinical Pregnancy Rate,	10 - 11 weeks after embryo transfer	defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer;
Number of Mature (Grade III Metaphase II) Oocytes Retrieved.	at the end of the stimulation.	—
Positive b-hCG Test	up to 5 weeks after treatment start	—

Countries

Denmark, France, Hungary, Switzerland, United Kingdom

Participant flow

Participants by arm

Arm	Count
hMG-IBSA New hMG preparation. Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.	135
Menopur Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.	135
Total	270

Baseline characteristics

Characteristic	Menopur	Total	hMG-IBSA
Age, Continuous	33.0 years STANDARD_DEVIATION 4.1	33.1 years STANDARD_DEVIATION 4.1	33.3 years STANDARD_DEVIATION 4
Race/Ethnicity, Customized Asian	6 participants	14 participants	8 participants
Race/Ethnicity, Customized Black	3 participants	4 participants	1 participants
Race/Ethnicity, Customized Caucasian	126 participants	252 participants	126 participants
Sex: Female, Male Female	135 Participants	270 Participants	135 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	46 / 135	42 / 135
serious Total, serious adverse events	5 / 135	8 / 135

Outcome results

Primary

Total Number of Oocytes Retrieved

Time frame: up to 24 days after treatment start

Arm	Measure	Value (MEAN)	Dispersion
hMG-IBSA	Total Number of Oocytes Retrieved	11.6 number of oocytes	Standard Deviation 6.6
Menopur	Total Number of Oocytes Retrieved	9.7 number of oocytes	Standard Deviation 5.9

p-value: 0.01295% CI: [0.43, 3.43]ANOVA

Secondary

17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;

Time frame: up to 23 days after treatment start

Arm	Measure	Value (MEAN)	Dispersion
hMG-IBSA	17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;	2613.8 pg/ml	Standard Deviation 1531.6
Menopur	17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;	2364.0 pg/ml	Standard Deviation 1441.6

Secondary

Clinical Pregnancy Rate,

defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer;

Time frame: 10 - 11 weeks after embryo transfer

Arm	Measure	Value (NUMBER)
hMG-IBSA	Clinical Pregnancy Rate,	33.3 percentage of participants
Menopur	Clinical Pregnancy Rate,	37.1 percentage of participants

p-value: 0.61Fisher Exact

Secondary

Controlled Ovarian Stimulation Duration (Days)

Time frame: up to 23 days after treatment start

Arm	Measure	Value (MEAN)	Dispersion
hMG-IBSA	Controlled Ovarian Stimulation Duration (Days)	10.2 days	Standard Deviation 1.3
Menopur	Controlled Ovarian Stimulation Duration (Days)	10.6 days	Standard Deviation 1.5

p-value: 0.02ANOVA

Secondary

Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)

Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded.

Time frame: up to 28 days after treatment start

Population: The population analysed corresponds to the patients who had at least one embryo to be analysed (i.e 120 participants in the hMG-IBSA group and 123 in the Menopur group). Of this, 119 in the hMG-IBSA group and 121 in the Menopur group underwent embryo transfer.

Arm	Measure	Value (NUMBER)	Dispersion
hMG-IBSA	Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)	63.3 percentage of participants	1.74
Menopur	Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)	63.3 percentage of participants	1.65

Secondary

Implantation Rate

defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100;

Time frame: 10-11 weeks after embryo transfer

Arm	Measure	Value (MEAN)	Dispersion
hMG-IBSA	Implantation Rate	29.1 percentage of embryos transferred	Standard Deviation 41
Menopur	Implantation Rate	28.2 percentage of embryos transferred	Standard Deviation 36.9

Secondary

Live Birth Rate

Time frame: 9 months after treatment

Arm	Measure	Value (NUMBER)
hMG-IBSA	Live Birth Rate	32.6 percentage of participants
Menopur	Live Birth Rate	36.3 percentage of participants

p-value: 0.61Fisher Exact

Secondary

Mean hMG Dose (Total);

Time frame: up to 22 days after treatment start

Arm	Measure	Value (MEAN)	Dispersion
hMG-IBSA	Mean hMG Dose (Total);	2171.4 Internationa Units (IU)	Standard Deviation 980
Menopur	Mean hMG Dose (Total);	2303.6 Internationa Units (IU)	Standard Deviation 906

p-value: 0.25ANOVA

Secondary

Number of Cleaved Embryos

Time frame: two days after insemination

Arm	Measure	Value (MEAN)	Dispersion
hMG-IBSA	Number of Cleaved Embryos	5.8 embryos	Standard Deviation 3.8
Menopur	Number of Cleaved Embryos	4.8 embryos	Standard Deviation 3.7

p-value: 0.04ANOVA

Secondary

Number of Mature (Grade III Metaphase II) Oocytes Retrieved.

Time frame: at the end of the stimulation.

Arm	Measure	Value (MEAN)	Dispersion
hMG-IBSA	Number of Mature (Grade III Metaphase II) Oocytes Retrieved.	10.3 oocytes	Standard Deviation 6
Menopur	Number of Mature (Grade III Metaphase II) Oocytes Retrieved.	8.2 oocytes	Standard Deviation 5.1

p-value: 0.002ANOVA

Secondary

Positive b-hCG Test

Time frame: up to 5 weeks after treatment start

Arm	Measure	Value (NUMBER)
hMG-IBSA	Positive b-hCG Test	43.7 percentage of participants
Menopur	Positive b-hCG Test	45.2 percentage of participants

p-value: 0.9Fisher Exact

Secondary

Ratio Mature/Total Number of Oocytes Retrieved.

Percentage of retrieved oocytes considered to be mature.

Time frame: at the end of the stimulation.

Arm	Measure	Value (NUMBER)
hMG-IBSA	Ratio Mature/Total Number of Oocytes Retrieved.	85 percentage of total oocytes retrieved
Menopur	Ratio Mature/Total Number of Oocytes Retrieved.	81 percentage of total oocytes retrieved

p-value: 0.004ANOVA

Secondary

Total Number of Inseminated Oocytes (IVF and ICSI)

number of oocytes that were inseminated via IVF or injected via ICSI technique.

Time frame: on the day of oocyte retrieval

Arm	Measure	Value (MEAN)	Dispersion
hMG-IBSA	Total Number of Inseminated Oocytes (IVF and ICSI)	10.8 oocytes	Standard Deviation 5.9
Menopur	Total Number of Inseminated Oocytes (IVF and ICSI)	8.4 oocytes	Standard Deviation 5

p-value: <0.001ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Total Number of Oocytes Retrieved

17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;

Clinical Pregnancy Rate,

Controlled Ovarian Stimulation Duration (Days)

Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)

Implantation Rate

Live Birth Rate

Mean hMG Dose (Total);

Number of Cleaved Embryos

Number of Mature (Grade III Metaphase II) Oocytes Retrieved.

Positive b-hCG Test

Ratio Mature/Total Number of Oocytes Retrieved.

Total Number of Inseminated Oocytes (IVF and ICSI)