Trial · NCT01121666
Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
NCT01121666, Phase 3, Completed, Finox AG; results first posted 2016-04-15
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment. Trials, record NCT01121666. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01121666
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
- NCT number
- NCT01121666
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 460 participants, actual
- Lead sponsor
- Finox AG
- Conditions
- Infertility
- Interventions
- Follitropin alfa
- First posted
- 2010-05-12
- Last updated
- 2016-04-15
- Other registries' IDs
- eudract:2010-019287-37
- Results first posted
- 2016-04-15
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oocytes Retrieved (Per Protocol Population) | 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment | As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes |
| Primary | Number of Oocytes Retrieved (Intention-to-treat Population) | 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment | As soon as ovulation criteria were reached, HCG was given to trigger ovulation and 34-36 hours later, oocytes were retrieved. If criteria for ovulation triggering could not be reached by FSH stimulation on day 16, treatment was to be stopped. The equivalence in the number of retrieved oocytes was tested using a pre-determined clinical equivalence margin of +/- 2.9 oocytes |
| Secondary | Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | Day 8 of stimulation | The number and size of follicles 12 mm or over in diameter at day 8 of stimulation were evaluated as secondary end-point. |
| Secondary | E2 Concentration at Day 8 and at Day of hCG Administration | Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment) | The serum concentration of oestradiol was assessed at day 8 and the day of hCG administration. |
| Secondary | Total Dose of r-hFSH Administered | Day of hCG administration (after maximum 16 days of r-hFSH treatment) | Total dose of r-hFSH required was assessed. |
| Secondary | Quality of Oocytes Retrieved | 34-36 hours after hCG administration | Number of patients with ovum pick-up |
| Secondary | Fertilisation Rate of Oocytes | 1 day after ovum pick-up | Fertilisation rate was assessed |
| Secondary | Embryo Quality: Mean Number of Blastomeres | Day 2 of OPU/fertilisation | Main embryo quality parameter "mean number of blastomeres" |
| Secondary | Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts | Day 1, 2, 3 and 5 of OPU/fertilisation | |
| Secondary | Number of Days of r-hFSH Stimulation | At the day of hCG administration, up to 16 days | Mean duration of stimulation was assessed. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Oocytes Retrieved (Per Protocol Population) | 34-36 hours after hCG administration and after maximum 16 days of r-hFSH treatment | Per protocol population | Number of retrieved oocytes | MEAN |
| SECONDARY | Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | Day 8 of stimulation | All participants were analyzed. | Number of follicles | MEAN |
| SECONDARY | E2 Concentration at Day 8 and at Day of hCG Administration | Day 8 of stimulation and at the day of hCG administration (after max. 16 days of r-FSH treatment) | All participants were analyzed. | pmol/ L | MEAN |
| SECONDARY | Total Dose of r-hFSH Administered | Day of hCG administration (after maximum 16 days of r-hFSH treatment) | All participants were analyzed. | IU | MEAN |
| SECONDARY | Quality of Oocytes Retrieved | 34-36 hours after hCG administration | Intention to treat population | Participants | NUMBER |
| SECONDARY | Fertilisation Rate of Oocytes | 1 day after ovum pick-up | Intention to treat population | percentage of oocytes | MEAN |
| SECONDARY | Embryo Quality: Mean Number of Blastomeres | Day 2 of OPU/fertilisation | Intention to treat population | Number of blastomeres at day 3 | MEAN |
| SECONDARY | Number of Participants With Cryopreserved 2PNs, Embryos/Blastocysts | Day 1, 2, 3 and 5 of OPU/fertilisation | Intention to treat population | Patients with cryopreservation | NUMBER |
| SECONDARY | Number of Days of r-hFSH Stimulation | At the day of hCG administration, up to 16 days | All participants were analyzed. | days | MEAN |
| SECONDARY | Number of Patients With Cycle Cancellation | Until child birth/miscarriage, up to the end of the study | Intention to treat population | Number of patients | NUMBER |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Oocytes Retrieved (Per Protocol Population) | AFOLIA-150 (Follitropin Alfa) | 10.8 | Standard Deviation 5.11 | Number of retrieved oocytes | |
| Number of Oocytes Retrieved (Per Protocol Population) | Gonal-f® (Follitropin Alfa) | 10.6 | Standard Deviation 6.06 | Number of retrieved oocytes | |
| Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | AFOLIA-150 (Follitropin Alfa) | ≥ 12 mm | 11.8 | Standard Deviation 4.73 | Number of follicles |
| Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | Gonal-f® (Follitropin Alfa) | ≥ 12 mm | 11.1 | Standard Deviation 4.23 | Number of follicles |
| Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | AFOLIA-150 (Follitropin Alfa) | ≥ 15 mm | 8.3 | Standard Deviation 3.81 | Number of follicles |
| Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | Gonal-f® (Follitropin Alfa) | ≥ 15 mm | 7.7 | Standard Deviation 3.60 | Number of follicles |
| Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | AFOLIA-150 (Follitropin Alfa) | ≥ 17 mm | 4.9 | Standard Deviation 3.29 | Number of follicles |
| Number and Size of Follicles ≥ 12 mm at Day 8 of Stimulation | Gonal-f® (Follitropin Alfa) | ≥ 17 mm | 4.5 | Standard Deviation 2.71 | Number of follicles |
| E2 Concentration at Day 8 and at Day of hCG Administration | AFOLIA-150 (Follitropin Alfa) | Day of hCG administration | 8982.3 | Standard Deviation 6535.3 | pmol/ L |
| E2 Concentration at Day 8 and at Day of hCG Administration | Gonal-f® (Follitropin Alfa) | Day of hCG administration | 7704.2 | Standard Deviation 5345.8 | pmol/ L |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AFOLIA-150 (Follitropin Alfa) | 249 | |
| Overall Study | STARTED | Gonal-f® (Follitropin Alfa) | 123 | |
| Overall Study | COMPLETED | AFOLIA-150 (Follitropin Alfa) | 220 | |
| Overall Study | COMPLETED | Gonal-f® (Follitropin Alfa) | 113 | |
| Overall Study | NOT COMPLETED | AFOLIA-150 (Follitropin Alfa) | 29 | |
| Overall Study | NOT COMPLETED | Gonal-f® (Follitropin Alfa) | 10 |
Source ClinicalTrials.gov
Adverse events34
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 | Injection site erythema | General disorders | AFOLIA-150 (Follitropin Alfa) | 68 | 249 | |
| other | Injection site erythema | General disorders | Gonal-f® (Follitropin Alfa) | 44 | 123 | |
| other | Injection site haematoma | General disorders | AFOLIA-150 (Follitropin Alfa) | 60 | 249 | |
| other | Injection site haematoma | General disorders | Gonal-f® (Follitropin Alfa) | 19 | 123 | |
| other | Headache | Nervous system disorders | AFOLIA-150 (Follitropin Alfa) | 55 | 249 | |
| other | Headache | Nervous system disorders | Gonal-f® (Follitropin Alfa) | 25 | 123 | |
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | AFOLIA-150 (Follitropin Alfa) | 55 | 249 | |
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | Gonal-f® (Follitropin Alfa) | 16 | 123 | |
| other | Injection site pain | General disorders | AFOLIA-150 (Follitropin Alfa) | 39 | 249 | |
| other | Injection site pain | General disorders | Gonal-f® (Follitropin Alfa) | 21 | 123 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AFOLIA-150 (Follitropin Alfa) | ||
| Total, all-cause mortality | Gonal-f® (Follitropin Alfa) | ||
| Total, other adverse events | AFOLIA-150 (Follitropin Alfa) | 182 | 249 |
| Total, other adverse events | Gonal-f® (Follitropin Alfa) | 83 | 123 |
| Total, serious adverse events | AFOLIA-150 (Follitropin Alfa) | 12 | 249 |
| Total, serious adverse events | Gonal-f® (Follitropin Alfa) | 3 | 123 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AFOLIA-150 (Follitropin Alfa) vs Gonal-f® (Follitropin Alfa): Number of Patients With Good Response | Trial comparisons |
| AFOLIA-150 (Follitropin Alfa) vs Gonal-f® (Follitropin Alfa): serious adverse events | 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.
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/NCT01121666
GET https://conductscience.org/api/trials/v1/NCT01121666/registered?page=2