Trial · NCT03088137
Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
NCT03088137, Phase 3, Completed, IVFarma LLC; results first posted 2019-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment. Trials, record NCT03088137. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03088137
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
- NCT number
- NCT03088137
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 118 participants, actual
- Lead sponsor
- IVFarma LLC
- Conditions
- Infertility, Female
- Interventions
- Follitropin alfa (Gonal-f), Follitropin alfa (Primapur)
- First posted
- 2017-03-23
- Last updated
- 2022-04-01
- Results first posted
- 2019-06-06
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Oocytes (Intention-to-Treat, ITT) | From date of randomization up to 18 days | The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the trigger of ovulation (hCG or GnRH-agonist). The equivalence in the number of retrieved oocytes was tested using a predetermined equivalence margin of +/- 3.4 oocytes. |
| Secondary | Number of Follicles With Size ≥ 16 mm | From date of randomization up to 16 days | The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration |
| Secondary | Mature Oocytes | From date of randomization up to 18 days | The number of mature oocytes (MII stage of development) |
| Secondary | Fertilised Oocytes | From date of randomization up to 19 days | The number of fertilised oocytes with the presence of two pronuclei: 2PN |
| Secondary | Percentage of Patients With Embryo Transfer | From date of randomization up to 25 days | The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up |
| Secondary | Total Dose of Follitropin Alfa | From date of randomization up to 16 days | The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU) |
| Secondary | Number of Days of Follitropin Alfa Treatment | From date of randomization up to 16 days | The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation) |
| Secondary | Number of Patients With Follitropin Alfa Dose Correction | From date of randomization up to 16 days | The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU) |
| Secondary | Number of Patients With Cycle Cancellation | From date of randomization up to 16 days | The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation) |
| Secondary | Number of No-responders | From date of randomization up to 8 days | The number of patients with no response to follitropin alfa treatment (absence of growing follicles, no any oocytes obtained at the day of ovum pick-up) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Oocytes (Intention-to-Treat, ITT) | From date of randomization up to 18 days | Intention-to-Treat | Number of retrieved oocytes | MEAN |
| SECONDARY | Number of Follicles With Size ≥ 16 mm | From date of randomization up to 16 days | Intention-to-Treat | Number of follicles | MEAN |
| SECONDARY | Mature Oocytes | From date of randomization up to 18 days | Intention-to-Treat | Number of mature oocytes (MII stage) | MEAN |
| SECONDARY | Fertilised Oocytes | From date of randomization up to 19 days | Intention-to-Treat | Number of oocytes with 2PN | MEAN |
| SECONDARY | Percentage of Patients With Embryo Transfer | From date of randomization up to 25 days | Per Protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Dose of Follitropin Alfa | From date of randomization up to 16 days | Intention-to-Treat | Total dose (IU) | MEAN |
| SECONDARY | Number of Days of Follitropin Alfa Treatment | From date of randomization up to 16 days | Intention-to-Treat | Days | MEAN |
| SECONDARY | Number of Patients With Follitropin Alfa Dose Correction | From date of randomization up to 16 days | Intention-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Cycle Cancellation | From date of randomization up to 16 days | Intention-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of No-responders | From date of randomization up to 8 days | Intention-to-Treat | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Oocytes (Intention-to-Treat, ITT) | Primapur (Follitropin Alfa) | 12.16 | Standard Deviation 7.28 | Number of retrieved oocytes | |
| Oocytes (Intention-to-Treat, ITT) | Gonal-f (Follitropin Alfa) | 11.62 | Standard Deviation 6.29 | Number of retrieved oocytes | |
| Number of Follicles With Size ≥ 16 mm | Primapur (Follitropin Alfa) | 12.09 | Standard Deviation 6.159 | Number of follicles | |
| Number of Follicles With Size ≥ 16 mm | Gonal-f (Follitropin Alfa) | 11.38 | Standard Deviation 4.965 | Number of follicles | |
| Mature Oocytes | Primapur (Follitropin Alfa) | 9.64 | Standard Deviation 6.270 | Number of mature oocytes (MII stage) | |
| Mature Oocytes | Gonal-f (Follitropin Alfa) | 9.86 | Standard Deviation 5.546 | Number of mature oocytes (MII stage) | |
| Fertilised Oocytes | Primapur (Follitropin Alfa) | 8.127 | Standard Deviation 6.608 | Number of oocytes with 2PN | |
| Fertilised Oocytes | Gonal-f (Follitropin Alfa) | 8.764 | Standard Deviation 5.850 | Number of oocytes with 2PN | |
| Percentage of Patients With Embryo Transfer | Primapur (Follitropin Alfa) | Embryo transfer on day 3 (%) | 11 | Participants | |
| Percentage of Patients With Embryo Transfer | Gonal-f (Follitropin Alfa) | Embryo transfer on day 3 (%) | 9 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Primapur (Follitropin Alfa) | 55 | |
| Overall Study | STARTED | Gonal-f (Follitropin Alfa) | 55 | |
| Overall Study | COMPLETED | Primapur (Follitropin Alfa) | 55 | |
| Overall Study | COMPLETED | Gonal-f (Follitropin Alfa) | 55 | |
| Overall Study | NOT COMPLETED | Primapur (Follitropin Alfa) | 0 | |
| Overall Study | NOT COMPLETED | Gonal-f (Follitropin Alfa) | 0 |
Source ClinicalTrials.gov
Adverse events40
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 | Spontaneous miscarriage | Pregnancy, puerperium and perinatal conditions | Primapur (Follitropin Alfa) | 0 | 55 | 0 |
| other | Spontaneous miscarriage | Pregnancy, puerperium and perinatal conditions | Gonal-f (Follitropin Alfa) | 2 | 55 | 2 |
| other | Early Toxicosis During Pregnancy | Pregnancy, puerperium and perinatal conditions | Primapur (Follitropin Alfa) | 0 | 55 | 0 |
| other | Early Toxicosis During Pregnancy | Pregnancy, puerperium and perinatal conditions | Gonal-f (Follitropin Alfa) | 1 | 55 | 1 |
| other | Abnormal vaginal bleeding | Pregnancy, puerperium and perinatal conditions | Primapur (Follitropin Alfa) | 0 | 55 | 0 |
| other | Abnormal vaginal bleeding | Pregnancy, puerperium and perinatal conditions | Gonal-f (Follitropin Alfa) | 1 | 55 | 1 |
| other | Menses | Reproductive system and breast disorders | Primapur (Follitropin Alfa) | 0 | 55 | 0 |
| other | Menses | Reproductive system and breast disorders | Gonal-f (Follitropin Alfa) | 1 | 55 | 1 |
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | Primapur (Follitropin Alfa) | 4 | 55 | 4 |
| other | Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | Gonal-f (Follitropin Alfa) | 2 | 55 | 2 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Primapur (Follitropin Alfa) | 0 | 55 |
| Total, all-cause mortality | Gonal-f (Follitropin Alfa) | 0 | 55 |
| Total, other adverse events | Primapur (Follitropin Alfa) | 21 | 55 |
| Total, other adverse events | Gonal-f (Follitropin Alfa) | 13 | 55 |
| Total, serious adverse events | Primapur (Follitropin Alfa) | 2 | 55 |
| Total, serious adverse events | Gonal-f (Follitropin Alfa) | 2 | 55 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Primapur (Follitropin Alfa) vs Gonal-f (Follitropin Alfa): Number of Patients With Cycle Cancellation | Trial comparisons |
| Primapur (Follitropin Alfa) vs Gonal-f (Follitropin Alfa): Number of Patients With Follitropin Alfa Dose Correction | Trial comparisons |
| Primapur (Follitropin Alfa) vs Gonal-f (Follitropin Alfa): Number of No-responders | Trial comparisons |
| Primapur (Follitropin Alfa) vs Gonal-f (Follitropin Alfa): deaths from any cause | Trial comparisons |
| Primapur (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/NCT03088137
GET https://conductscience.org/api/trials/v1/NCT03088137/results?page=2