| Primary | Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP) | Number of subjects who self-administered the IMP were presented in this outcome measure. | The ITT population included all the subjects who received at least 1 dose of the IMP. | Posted | | Number | | subjects | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | GONAL-f® | GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed. |
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| Secondary | Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator | Investigator evaluated the use of GONAL-f® prefilled pen in subjects as very satisfactory, satisfactory and average satisfaction. | The ITT population included all the subjects who received at least 1 dose of the IMP. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome. | Posted | | Number | | subjects | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | GONAL-f® | GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed. |
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| Secondary | Evaluation of the Information Given to the Subjects on the Pen's Utilization | Subjects were provided with the information on Pen's utilization via training session and in the form of information brochure. Subjects assessed both the methods using the following responses: satisfactory, satisfactory, unsatisfactory and very unsatisfactory. | The ITT population. Here "Overall Number of Subjects Analyzed" signifies those subjects who were evaluable for this outcome and "Number Analyzed" signifies those who were evaluable for the specified category. | Posted | | Number | | subjects | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | GONAL-f® | GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed. |
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| Secondary | Duration of Ovarian Stimulation With GONAL-f® | Stimulation duration was defined as the duration (in days) for which subjects underwent GONAL-f® treatment. | The ITT population included all the subjects who received, at least 1 dose of the IMP. | Posted | | Median | Full Range | days | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | GONAL-f® | GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed. |
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| Secondary | Mean Number of Embryos Transferred | | The ITT population included all the subjects who received at least 1 dose of the IMP. Here "Number of Participants Analyzed" signifies those subjects who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | embryos | | End of Stimulation period (up to a maximum 26 days) | | | | ID | Title | Description |
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| OG000 | GONAL-f® | GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed. |
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| Secondary | Total and Average Daily Dose of GONAL-f® | | The ITT population included all the subjects who received at least 1 dose of the IMP. | Posted | | Mean | Standard Deviation | International Units (IU) | | Up to 26 days | | | | ID | Title | Description |
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| OG000 | GONAL-f® | GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed. |
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| Secondary | Pregnancy Rate in Subjects Receiving Stimulation by Ovulation Induction (OI) or Artificial Insemination (IUI) | Pregnancy rate was defined as the percentage of subjects with diagnosis of pregnancy, who underwent OI/IUI. Clinical pregnancy: Evidence of pregnancy by clinical or ultrasound parameters at 12 weeks after fertilization. Biochemical pregnancy: Evidence of conception based only on biochemical data in the serum or urine before ultrasound evidence of a gestational sac. Ongoing pregnancy was defined when the pregnancy had completed 20 weeks of gestation. | The ITT population included all the subjects who received, at least 1 dose of the IMP. "Number of Participants Analyzed" signifies ITT (OI/IUI) subjects who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | Up to 20 Weeks of Gestation | | | | ID | Title | Description |
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| OG000 | GONAL-f® | GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed. |
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| Secondary | Number of Subjects With Live Birth | Number of subjects whose stimulation with the IMP resulted in the birth of a baby were reported. | Per Protocol (PP) population was defined as the group of subjects who completed the study, having returned their completed questionnaire and who did not present any major protocol deviations. | Posted | | Number | | subjects | | End of Gestation period, assessed up to a maximum of 1 year | | | | ID | Title | Description |
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| OG000 | GONAL-f® | GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed. |
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| Secondary | Number of Subjects With Local Tolerance at GONAL-f ® Injection Site as Assessed by Investigator | Local tolerance at the GONAL-f ® injection site was assessed for the presence of pain, swelling/welt, redness, itch and haematoma. | ITT population included all the subjects who received at least 1 dose of the investigational medicinal product. | Posted | | Number | | subjects | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | GONAL-f® | GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed. |
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| Secondary | Number of Subjects With at Least 1 Adverse Event | An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerged or worsened relative to baseline (i.e. present at the initial study visit) during a clinical study with an investigational product, regardless of causal relationship and even if no investigational product has been administered. | The tolerance analysis set included of all the subjects who were presented at the inclusion visit. | Posted | | Number | | subjects | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | GONAL-f® | GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed. |
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| Secondary | Number of Subjects Taking at Least 1 Concomitant Treatment | | The tolerance analysis set included of all the subjects who were presented at the inclusion visit. | Posted | | Number | | subjects | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | GONAL-f® | GONAL-f® was administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who underwent ovulation induction (OI)/ artificial insemination (IUI) and between 150 and 225 IU per day for subjects who underwent in-vitro fertilization (IVF). For subjects who underwent OI/ IUI the dose was increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response was observed. |
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