Trial · NCT04854707
An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
NCT04854707, Completed, IVFarma LLC; results first posted 2021-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data. Trials, record NCT04854707. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04854707
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
- NCT number
- NCT04854707
- Status
- Completed
- Enrollment
- 5,484 participants, actual
- Lead sponsor
- IVFarma LLC
- Conditions
- Reproductive Issues, Reproductive Disorder, Fertility Disorders, Fertility Issues, Gynecologic Disease, IVF
- Interventions
- Follitropin Alfa, Follicle Stimulating Hormone/Luteinizing Hormone, Follitropin Alfa, Follitropin Alfa, Follicle Stimulating Hormone/Luteinizing Hormone
- First posted
- 2021-04-22
- Last updated
- 2021-10-22
- Results first posted
- 2021-10-22
- Limitations and caveats
The real-world patient data analysed in this study were representative, showing the ability of follitropin biosimilars to develop both folliculogenesis and clinical pregnancy in a nonselected population. Additional comparative studies are needed to confirm the efficacy of the biosimilars in patients with classified types of infertility causes, including unexplained infertility.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oocytes Retrieved | From date of start of ovarian stimulation with follitropin alpha up to 15 days | The total number of retrieved oocytes at the day of ovum pick-up. No more than 37 hours from the introduction of the ovulation inducer (HCG or GnRH-agonist). Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). |
| Primary | Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer | At least 6 weeks after embryo transfer | Ongoing clinical pregnancy per embryo transfer (detection of gestational sac and heartbeat from 6 weeks after transfer), n (ongoing pregnancy rate per transfer with known outcome, %). Due to delayed embryo transfers, the analysed population for "Ongoing clinical pregnancy per embryo transfer" was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2007 embryo transfers (1542 with known outcome); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2213 embryo transfers (1800 with known outcome); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 1809 embryo transfers (1466 with known outcome) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 404 embryo transfers (334 with known outcome). |
| Secondary | Number of Mature Oocytes | From date of start of ovarian stimulation with follitropin alpha up to 15 days | Mature oocytes (MII stage of development). Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). |
| Secondary | Number of Fertilized Oocytes | From date of start of ovarian stimulation with follitropin alpha up to 16 days | Fertilization rate (FR) is percentage of transformation of oocytes into two pronuclei (presence of two pronuclei: zygotes with 2PN). Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). |
| Secondary | Total Dose of Follitropin Alpha Biosimilar Protocol, IU | From date of start of ovarian stimulation with follitropin alpha up to 16 days | Mean dose of follitropin alpha biosimilar for ovarian stimulation. Due to lack of efficacy of the therapy (ovarian stimulation was not completed and oocytes were not retrieved) the analysed population was: (1) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH - 2625 participants (lack of efficacy: 78 participants, the analysed population was 2547 participants); (2) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH - 2859 participants (lack of efficacy: 89, the analysed population was 2770); (3) Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH - 2183 participants (lack of efficacy: 59, the analysed population was 2124) and (4) Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH - 676 participants (lack of efficacy: 30, the analysed population was 646). |
Source ClinicalTrials.gov
Outcomes5
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 | From date of start of ovarian stimulation with follitropin alpha up to 15 days | Arm Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH is combined group for primary and secondary outcome measures and consist of patients from Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH and Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH. | The total number of retrieved oocytes | MEAN |
| PRIMARY | Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer | At least 6 weeks after embryo transfer | Arm Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH is combined group for primary and secondary outcome measures and consist of patients from Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH and Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH. | Percetnage of patients (%) | NUMBER |
| SECONDARY | Number of Mature Oocytes | From date of start of ovarian stimulation with follitropin alpha up to 15 days | Arm Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH is combined group for primary and secondary outcome measures and consist of patients from Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH and Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH. | Number of mature oocytes | MEAN |
| SECONDARY | Number of Fertilized Oocytes | From date of start of ovarian stimulation with follitropin alpha up to 16 days | Arm Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH is combined group for primary and secondary outcome measures and consist of patients from Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH and Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH. | zygotes with 2PN | MEAN |
| SECONDARY | Total Dose of Follitropin Alpha Biosimilar Protocol, IU | From date of start of ovarian stimulation with follitropin alpha up to 16 days | IU (International Units) | MEAN |
Source ClinicalTrials.gov
Results by group25
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 | Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH | 8.6 | Standard Deviation 6.8 | The total number of retrieved oocytes | |
| Number of Oocytes Retrieved | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH | 10.3 | Standard Deviation 7.4 | The total number of retrieved oocytes | |
| Number of Oocytes Retrieved | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH | 10.5 | Standard Deviation 7.5 | The total number of retrieved oocytes | |
| Number of Oocytes Retrieved | Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH | 9.6 | Standard Deviation 7.0 | The total number of retrieved oocytes | |
| Number of Oocytes Retrieved | The Overall Protocols | 9.5 | Standard Deviation 7.2 | The total number of retrieved oocytes | |
| Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer | Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH | 39.3 | 95% Confidence Interval 36.9 to 41.7 | Percetnage of patients (%) | |
| Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists/Agonists of GnRH | 37.6 | 95% Confidence Interval 35.3 to 39.8 | Percetnage of patients (%) | |
| Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH | 37.9 | 95% Confidence Interval 35.5 to 40.5 | Percetnage of patients (%) | |
| Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer | Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH | 35.9 | 95% Confidence Interval 30.8 to 41.1 | Percetnage of patients (%) | |
| Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer | The Overall Protocols | 38.4 | 95% Confidence Interval 35.9 to 40.2 | Percetnage of patients (%) |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH | 2,625 | |
| Overall Study | STARTED | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH | 2,183 | |
| Overall Study | STARTED | Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH | 676 | |
| Overall Study | COMPLETED | Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH | 2,547 | |
| Overall Study | COMPLETED | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH | 2,124 | |
| Overall Study | COMPLETED | Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH | 646 | |
| Overall Study | NOT COMPLETED | Mixed Protocols: Recombinant and Urinary-derived Gonadotropins and Antagonists/Agonists of GnRH | 78 | |
| Overall Study | NOT COMPLETED | Monoprotocols: Follitropin Alpha Biosimilar Only and Antagonists of GnRH | 59 | |
| Overall Study | NOT COMPLETED | Monoprotocols: Follitropin Alpha Biosimilar Only and Agonist of GnRH | 30 |
Source ClinicalTrials.gov
Adverse events1
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 pain | Skin and subcutaneous tissue disorders | The Overall Protocols | 657 | 5,484 | 657 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | The Overall Protocols | 0 | 5,484 |
| Total, other adverse events | The Overall Protocols | 657 | 5,484 |
| Total, serious adverse events | The Overall Protocols | 0 | 5,484 |
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 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.
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