Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF
Public ClinicalTrials.gov record NCT01687712. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase III Investigator and Assessor Blinded 1:1 Randomized, Parallel-group Multicenter Study to Compare Efficacy and Safety of Two r-hFSH Formulations (AFOLIA vs Gonal-f® RFF) in Normal Ovulatory Women 35 to 42 Years Old Undergoing in Vitro Fertilization
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f® RFF.
Study identification
- NCT ID
- NCT01687712
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 35 Years to 42 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 25, 2013 (Actual)
- Primary completion
- Sep 10, 2015 (Actual)
- Completion
- Nov 14, 2016 (Actual)
- Last update posted
- Dec 5, 2017
2013 – 2016
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Physicians Research Group | Tempe | Arizona | 85284 | — |
| HRC Fertility | Encino | California | 91436 | — |
| Reproductive Associates of Delaware | Newark | Delaware | 19713 | — |
| FL Fertility Institution | Tampa | Florida | 33759 | — |
| Georgia Reproductive Specialists | Atlanta | Georgia | 30342 | — |
| Fertility Centers of Illinois | Chicago | Illinois | 60610 | — |
| In Via Fertility Specialists | Hoffman Estate | Illinois | 60169 | — |
| Shady Grove Fertility RSC | Rockville | Maryland | 20850 | — |
| Nevada Center for Reproductive Medicine | Reno | Nevada | 89519 | — |
| Cooper Institute of Reproductive Hormonal Disorders, P.C. | Marlton | New Jersey | 08053 | — |
| Institute for Reproductive Health | Cincinnati | Ohio | 45209 | — |
| Abington Reproductive Medicine | Abington | Pennsylvania | 19001 | — |
| Main Line Fertility Center | Bryn Mawr | Pennsylvania | 19010 | — |
| Shady Grove Fertility RSC, Chesterbrook, PA | Chesterbrook | Pennsylvania | 19087 | — |
| University of Penn | Philadelphia | Pennsylvania | 19104 | — |
| Fertility Associates of Memphis | Memphis | Tennessee | 38120 | — |
| Texas Fertility Center | Austin | Texas | 78731 | — |
| Center for Assisted Reproduction | Bedford | Texas | 75022 | — |
| Fertility Specialists of Houston | Houston | Texas | 77054 | — |
| Houston Fertility Institute | Houston | Texas | 77063 | — |
| Center of Reproducitve Medicine | Webster | Texas | 77598 | — |
| Jones Institute for Reproductive Medicine | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01687712, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 5, 2017 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01687712 live on ClinicalTrials.gov.