Trial · NCT01687712
Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF
NCT01687712, Phase 3, Completed, Fertility Biotech AG; results first posted 2017-10-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF. Trials, record NCT01687712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01687712
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF
- NCT number
- NCT01687712
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,100 participants, actual
- Lead sponsor
- Fertility Biotech AG
- Conditions
- Infertility
- Interventions
- AFOLIA, Gonal-f® RFF
- First posted
- 2012-09-19
- Last updated
- 2017-12-05
- Results first posted
- 2017-10-18
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population | Six weeks post embryo transfer | Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the ITT population of the respective treatment arm. |
| Primary | Clinical Pregnancy Rate After One Cycle of Treatment - PP Population | Six weeks post embryo transfer | Clinical pregnancy was defined as presence of at least one intrauterine gestational sac and fetal heart activity as demonstrated by vaginal ultrasound at six weeks (42 +/- 1 day) post ET (Visit 11). The clinical pregnancy rate is the proportion of subjects who achieve clinical pregnancy, relative to the number of patients in the PP population of the respective treatment arm. |
| Secondary | Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1 | Measured at discretionary visits between Days 9 and 15 after FSH starts | The number of days of r-hFSH stimulation a subject received during Cycle 1. |
| Secondary | Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1 | Measured at discretionary visits between Days 9 and 15 after FSH starts. | The total dose of r-hFSH that subjects received during Cycle 1. |
| Secondary | Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1 | Measured at discretionary visits between Days 9 and 15 after FSH starts. | The mean dose of r-hFSH that subjects received in a day during Cycle 1. |
| Secondary | Number of Oocytes Retrieved - Cycle 1 | Visit 8, 34-36 hours after hCG administration | The number of oocytes retrieved per subject, following hCG administration in Cycle 1. |
| Secondary | Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1 | Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days). | Number of subjects reporting at least one dermal response to r-hFSH injection and number of subjects reporting no dermal responses. |
| Secondary | Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1 | Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days). | Dermal response to r-hFSH injection as assessed by the investigator and categorized according to severity of reaction |
| Secondary | Overall Summary of Adverse Events (AEs) - Cycle 1 | Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months). | Summary of AEs, including the number of subjects experiencing to following during Cycle 1: At least one AE At least one treatment related AE At least one serious AE At least one AE leading to discontinuation of study drug At least one AE due to pregnancy complication |
| Secondary | Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1 | Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10). | Summary of the number of subjects with mild, moderate and severe OHSS. The total number of subjects with OHSS is also included. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population | Six weeks post embryo transfer | Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Clinical Pregnancy Rate After One Cycle of Treatment - PP Population | Six weeks post embryo transfer | Per-protocol population, defined as a subset of the ITT population composed of all patients without any major protocol deviation (i.e. one which would affect the primary efficacy endpoint assessment). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1 | Measured at discretionary visits between Days 9 and 15 after FSH starts | Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. | days | MEAN |
| SECONDARY | Exposure to r-hFSH Injections: Total Dose of r-hFSH (IU) - Cycle 1 | Measured at discretionary visits between Days 9 and 15 after FSH starts. | Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. | international unit (IU) | MEAN |
| SECONDARY | Exposure to r-hFSH Injections: Daily Dose of r-hFSH (IU) - Cycle 1 | Measured at discretionary visits between Days 9 and 15 after FSH starts. | Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. | international unit (IU) | MEAN |
| SECONDARY | Number of Oocytes Retrieved - Cycle 1 | Visit 8, 34-36 hours after hCG administration | Intention to treat population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. | Oocytes retrieved | MEAN |
| SECONDARY | Local and Systemic Adverse Events: Dermal Response to Injection - Cycle 1 | Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH Start through to Day 16 after start of FSH (16 days). | Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Local and Systemic Adverse Events: Dermal Response to Injection by Severity - Cycle 1 | Measure recorded in the Patient Diary which is maintained through entire FSH treatment, from FSH through to Day 16 after start of FSH (16 days). | Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Summary of Adverse Events (AEs) - Cycle 1 | Measured from the start of FSH treatment through to either the end FSH treatment + 30 days (up to 46 days) or to the last Telephone Follow-up / Live Birth Questionnaire on pregnancy outcome (if applicable) (up to 10 months). | Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Adverse Events of Special Interest: Ovarian Hyperstimulation Syndrome (OHSS) - Cycle 1 | Measured either 3 days after ooctye pick up (Visit 9) or 18 +/- 1 days after oocyte pick up (Visit 10). | Safety population, defined as all randomized subjects who received at least one dose of study treatment, based on their randomization. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population | AFOLIA | Yes | 114 | Participants | |
| Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population | Gonal-f® RFF | Yes | 138 | Participants | |
| Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population | AFOLIA | No | 435 | Participants | |
| Clinical Pregnancy Rate After One Cycle of Treatment - ITT Population | Gonal-f® RFF | No | 413 | Participants | |
| Clinical Pregnancy Rate After One Cycle of Treatment - PP Population | AFOLIA | Yes | 108 | Participants | |
| Clinical Pregnancy Rate After One Cycle of Treatment - PP Population | Gonal-f® RFF | Yes | 125 | Participants | |
| Clinical Pregnancy Rate After One Cycle of Treatment - PP Population | AFOLIA | No | 378 | Participants | |
| Clinical Pregnancy Rate After One Cycle of Treatment - PP Population | Gonal-f® RFF | No | 369 | Participants | |
| Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1 | AFOLIA | 10.8 | Standard Deviation 1.72 | days | |
| Exposure to r-hFSH Injections: Days of r-hFSH Stimulation - Cycle 1 | Gonal-f® RFF | 11.0 | Standard Deviation 1.67 | days |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Cycle 1 | STARTED | AFOLIA | 549 | |
| Cycle 1 | STARTED | Gonal-f® RFF | 551 | |
| Cycle 1 | Received hCG | AFOLIA | 516 | |
| Cycle 1 | Received hCG | Gonal-f® RFF | 520 | |
| Cycle 1 | Oocyte/Ovum Pick Up | AFOLIA | 513 | |
| Cycle 1 | Oocyte/Ovum Pick Up | Gonal-f® RFF | 517 | |
| Cycle 1 | Fertilization Performed | AFOLIA | 508 | |
| Cycle 1 | Fertilization Performed | Gonal-f® RFF | 512 | |
| Cycle 1 | Embryo Transfer | AFOLIA | 466 | |
| Cycle 1 | Embryo Transfer | Gonal-f® RFF | 483 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events1,692
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 | Anaemia | Blood and lymphatic system disorders | AFOLIA - Cycle 1 | 0 | 549 | |
| other | Anaemia | Blood and lymphatic system disorders | Gonal-f® RFF - Cycle 1 | 2 | 551 | |
| other | Anaemia | Blood and lymphatic system disorders | AFOLIA - Cycle 2 | 0 | 109 | |
| other | Anaemia | Blood and lymphatic system disorders | Gonal-f® RFF - Cycle 2 | 0 | 120 | |
| other | Anaemia | Blood and lymphatic system disorders | AFOLIA - Cycle 3 | 0 | 28 | |
| other | Anaemia | Blood and lymphatic system disorders | Gonal-f® RFF - Cycle 3 | 0 | 24 | |
| other | Palpitations | Cardiac disorders | AFOLIA - Cycle 1 | 1 | 549 | |
| other | Palpitations | Cardiac disorders | Gonal-f® RFF - Cycle 1 | 0 | 551 | |
| other | Palpitations | Cardiac disorders | AFOLIA - Cycle 2 | 0 | 109 | |
| other | Palpitations | Cardiac disorders | Gonal-f® RFF - Cycle 2 | 0 | 120 |
1 to 10 of 1,692Source ClinicalTrials.gov
See all 1,692 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AFOLIA - Cycle 1 | 0 | 549 |
| Total, all-cause mortality | Gonal-f® RFF - Cycle 1 | 1 | 551 |
| Total, all-cause mortality | AFOLIA - Cycle 2 | 0 | 109 |
| Total, all-cause mortality | Gonal-f® RFF - Cycle 2 | 0 | 120 |
| Total, all-cause mortality | AFOLIA - Cycle 3 | 0 | 28 |
| Total, all-cause mortality | Gonal-f® RFF - Cycle 3 | 0 | 24 |
| Total, other adverse events | AFOLIA - Cycle 1 | 403 | 549 |
| Total, other adverse events | Gonal-f® RFF - Cycle 1 | 391 | 551 |
| Total, other adverse events | AFOLIA - Cycle 2 | 69 | 109 |
| Total, other adverse events | Gonal-f® RFF - Cycle 2 | 66 | 120 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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.
GET https://conductscience.org/api/trials/v1/NCT01687712
GET https://conductscience.org/api/trials/v1/NCT01687712/results?page=2