Trial · NCT01312766

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

NCT01312766, Phase 3, Completed, IBSA Institut Biochimique SA; results first posted 2014-08-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients. Trials, record NCT01312766. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01312766

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
NCT number: NCT01312766
Status: Completed
Phases: Phase 3
Enrollment: 270 participants, actual
Lead sponsor: IBSA Institut Biochimique SA
Conditions: Infertility
Interventions: Menotropins, Menotropins
First posted: 2011-03-11
Last updated: 2016-07-22
Other registries' IDs: eudract:2010-021021-13
Results first posted: 2014-08-15

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Total Number of Oocytes Retrieved	up to 24 days after treatment start
Secondary	Mean hMG Dose (Total);	up to 22 days after treatment start
Secondary	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.
Secondary	Positive b-hCG Test	up to 5 weeks after treatment start
Secondary	Controlled Ovarian Stimulation Duration (Days)	up to 23 days after treatment start
Secondary	17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;	up to 23 days after treatment start
Secondary	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;
Secondary	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;
Secondary	Number of Mature (Grade III Metaphase II) Oocytes Retrieved.	at the end of the stimulation.
Secondary	Ratio Mature/Total Number of Oocytes Retrieved.	at the end of the stimulation.	Percentage of retrieved oocytes considered to be mature.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Total Number of Oocytes Retrieved	up to 24 days after treatment start		number of oocytes	MEAN
SECONDARY	Mean hMG Dose (Total);	up to 22 days after treatment start		Internationa Units (IU)	MEAN
SECONDARY	Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)	up to 28 days after treatment start	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.	percentage of participants	NUMBER
SECONDARY	Positive b-hCG Test	up to 5 weeks after treatment start		percentage of participants	NUMBER
SECONDARY	Controlled Ovarian Stimulation Duration (Days)	up to 23 days after treatment start		days	MEAN
SECONDARY	17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection;	up to 23 days after treatment start		pg/ml	MEAN
SECONDARY	Implantation Rate	10-11 weeks after embryo transfer		percentage of embryos transferred	MEAN
SECONDARY	Clinical Pregnancy Rate,	10 - 11 weeks after embryo transfer		percentage of participants	NUMBER
SECONDARY	Number of Mature (Grade III Metaphase II) Oocytes Retrieved.	at the end of the stimulation.		oocytes	MEAN
SECONDARY	Ratio Mature/Total Number of Oocytes Retrieved.	at the end of the stimulation.		percentage of total oocytes retrieved	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Total Number of Oocytes Retrieved	hMG-IBSA	11.6	Standard Deviation 6.6	number of oocytes
Total Number of Oocytes Retrieved	Menopur	9.7	Standard Deviation 5.9	number of oocytes
Mean hMG Dose (Total);	hMG-IBSA	2171.4	Standard Deviation 980	Internationa Units (IU)
Mean hMG Dose (Total);	Menopur	2303.6	Standard Deviation 906	Internationa Units (IU)
Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)	hMG-IBSA	63.3	1.74	percentage of participants
Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo)	Menopur	63.3	1.65	percentage of participants
Positive b-hCG Test	hMG-IBSA	43.7		percentage of participants
Positive b-hCG Test	Menopur	45.2		percentage of participants
Controlled Ovarian Stimulation Duration (Days)	hMG-IBSA	10.2	Standard Deviation 1.3	days
Controlled Ovarian Stimulation Duration (Days)	Menopur	10.6	Standard Deviation 1.5	days

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	hMG-IBSA	135
Overall Study	STARTED	Menopur	135
Overall Study	COMPLETED	hMG-IBSA	129
Overall Study	COMPLETED	Menopur	130
Overall Study	NOT COMPLETED	hMG-IBSA	6
Overall Study	NOT COMPLETED	Menopur	5

Source ClinicalTrials.gov

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal distension	Gastrointestinal disorders	hMG-IBSA	18	135	23
other	Abdominal distension	Gastrointestinal disorders	Menopur	14	135	18
other	Abdominal pain upper	Gastrointestinal disorders	hMG-IBSA	7	135	7
other	Abdominal pain upper	Gastrointestinal disorders	Menopur	6	135	9
other	fatigue	General disorders	hMG-IBSA	9	135	10
other	fatigue	General disorders	Menopur	8	135	9
other	Headache	Nervous system disorders	hMG-IBSA	21	135	33
other	Headache	Nervous system disorders	Menopur	20	135	32
other	Hot flushes	Vascular disorders	hMG-IBSA	11	135	13
other	Hot flushes	Vascular disorders	Menopur	2	135	2

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	hMG-IBSA
Total, all-cause mortality	Menopur
Total, other adverse events	hMG-IBSA	46	135
Total, other adverse events	Menopur	42	135
Total, serious adverse events	hMG-IBSA	5	135
Total, serious adverse events	Menopur	8	135

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
hMG-IBSA vs Menopur: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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