An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
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| ClinicalTrials.gov Identifier: NCT04854707 |
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Recruitment Status :
Completed
First Posted : April 22, 2021
Results First Posted : October 22, 2021
Last Update Posted : October 22, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Reproductive Issues Reproductive Disorder Fertility Disorders Fertility Issues Gynecologic Disease IVF | Drug: Follitropin Alfa Drug: Follicle Stimulating Hormone/Luteinizing Hormone |
A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included:
monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.
| Study Type : | Observational |
| Actual Enrollment : | 5484 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | An Observational Study "FOLLITROPIN" Comparing the Efficacy of Follitropin Alpha Biosimilar: the Real-world Data |
| Actual Study Start Date : | January 12, 2020 |
| Actual Primary Completion Date : | December 20, 2020 |
| Actual Study Completion Date : | January 20, 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH
The ovarian stimulation (OS) protocols included monotherapy protocols with using follitropin alpha biosimilar only and antagonists/agonists of of gonadotropin-releasing hormone (GnRH): ganirelix, cetrorelix, triptorelin, buserelin.
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Drug: Follitropin Alfa
Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH or agonist of GnRH.
Other Names:
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Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH
The OS protocols included: mixed protocols (recombinant with addition of urinary-derived gonadotropins) and antagonists/agonists of GnRH (ganirelix, cetrorelix, triptorelin, buserelin), where follitropin alpha biosimilar used for at least 5 days during OS.
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Drug: Follicle Stimulating Hormone/Luteinizing Hormone
Subcutaneous injection of follitropin alpha biosimilar, with daily dose 100-300 IU for at least 5 days, than added another gonadotropin for a maximum of 10 days, using antagonists of GnRH or agonist of GnRH.
Other Names:
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Monoprotocols: follitropin alpha biosimilar only and antagonists of GnRH
The OS protocols included: monotherapy protocols with using only follitropin alpha biosimilar and antagonists of GnRH.
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Drug: Follitropin Alfa
Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using antagonists of GnRH only for suppression.
Other Names:
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Monoprotocols: follitropin alpha biosimilar only and agonist of GnRH
The OS protocol included: monotherapy protocols with using only follitropin alpha biosimilar and agonists of GnRH.
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Drug: Follitropin Alfa
Subcutaneous injection of follitropin alpha biosimilar only, with daily dose 100-300 IU for 10 days, maximum of 15 days, using agonists of GnRH only for suppression.
Other Names:
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The overall protocols
The OS protocols included: (1) Monoprotocols: follitropin alpha biosimilar only and antagonists/agonists of GnRH, (2) Mixed protocols: recombinant and urinary-derived gonadotropins and antagonists/agonists of GnRH
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Drug: Follicle Stimulating Hormone/Luteinizing Hormone
Overall ovarian stimulation protocols with follitropin alpha biosimilar for at least 5 days+other recombinant and menotropins and short (antagonists of GnRH) or long protocol (agonist of GnRH).
Other Names:
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- Number of Oocytes Retrieved [ Time Frame: 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).
- Percentage of Participants With Ongoing Clinical Pregnancy Per Embryo Transfer [ Time Frame: 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).
- Number of Mature Oocytes [ Time Frame: 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).
- Number of Fertilized Oocytes [ Time Frame: 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).
- Total Dose of Follitropin Alpha Biosimilar Protocol, IU [ Time Frame: 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).
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| Ages Eligible for Study: | 20 Years to 43 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Women with established causes of infertility and indications for the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation "On the use of assisted reproductive technologies, contraindications and limitations to their use" No. 107 n dated August 30, 2012.
- Infertility due to female and/or male factor.
- Presence of ovaries accessible for aspiration of follicles.
- Anatomical and functional capability of uterus to bear pregnancy.
Exclusion Criteria:
- Women with established contraindications to the use of ART methods, according to the Order of the Ministry of Health of the Russian Federation "On the use of assisted reproductive technologies, contraindications and limitations to their use" No. 107 n dated August 30, 2012.
- Presence of pregnancy
- Hypersensitivity to follitropin alfa or excipients.
- Ovarian cysts (not associated with polycystic ovarian syndrome), uterine hemorrhage of unclear etiology
- Premature ovarian failure
- Presence of clinically significant systemic disease
- Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
- Neoplasia
- Narcomania, alcoholism
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04854707
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| Principal Investigator: | Dilorom Kamilova, PhD | MD Medical Group |
Documents provided by IVFarma LLC:
| Responsible Party: | IVFarma LLC |
| ClinicalTrials.gov Identifier: | NCT04854707 |
| Other Study ID Numbers: |
IVF-2020 |
| First Posted: | April 22, 2021 Key Record Dates |
| Results First Posted: | October 22, 2021 |
| Last Update Posted: | October 22, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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follitropin alpha follicle-stimulating hormone in vitro fertilization assisted reproductive technologies |
biosimilar follitropin alfa real-world data |
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Infertility Disease Pathologic Processes Menotropins Hormones Follicle Stimulating Hormone |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Fertility Agents, Female Fertility Agents Reproductive Control Agents |