Infertility, FemalePhase 3NCT03088137

Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

A Phase 3 study testing Follitropin alfa (Gonal-f) and Follitropin alfa (Primapur) in people with Infertility, Female, run by IVFarma LLC at 3 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI Read more about this study

Who is it for?: Ages 20 to 35 years, women only
Conditions the study is for: Infertility, Female
What is being tested?: Follitropin alfa (Gonal-f) and Follitropin alfa (Primapur)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 3 sitesRussia
Study dates: 8 Feb 2017to 17 Aug 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 35 years
Women only
No healthy volunteers
Adult

Who may be able to join

Infertility due to tubal factor and/or male factor
Age between 20 and 35 years with regular menstrual cycles of 21-35 days
First or second cycle in the present series of ART
BMI (body mass index) ≥ 18 ≤ 30 kg/m2
Basal FSH (follicle stimulating hormone) < 10 IU/L (cycle day 2-5)
E2 (estradiol) levels < 50pg/mL (cycle day 2)

Show all 10Show fewer

AMH (anti-mullerian hormone) ≥ 1.0 ng/ml
Antral follicle ≥ 4 to ≤ 15 follicles (both ovaries)
Presence of both ovaries and normal uterine cavity
Informed consent

Who cannot join

Presence of pregnancy
Hypersensitivity to follitropin alfa
Ovarian cysts
History of ≥2 succeeding ART (assisted reproductive technology) cycles IVF (in vitro fertilization) and/or ICSI (Intracytoplasmic sperm injection) before the study cycle
Previous history of severe ovarian hyperstimulation syndrome
Presence of polycystic ovaries (PCO)

Show all 19Show fewer

Presence of endometriosis and hydrosalpinx
Presence of uterine disorders
History of poor (< 4 oocytes) or hyper (> 25 oocytes) responses to FSH treatment at dose 150 IU and GnRH-antagonist (gonadotropin-releasing hormone) protocol
Premature ovarian failure
Ectopic pregnancy (3 month before the study cycle)
Presence of clinically significant systemic disease
Presence of chronic cardiovascular, hepatic, renal or pulmonary disease
Presence of endocrine disorder
Neoplasia
Male infertility without mobile spermatozoa in the ejaculate, that need MESA (Microsurgical epididymal sperm aspiration)/TESE (testicular sperm extraction)/TESA (testicular sperm aspiration)
Smoking > 10 cigarettes/day
Narcomania, alcoholism
Planned PGS (preimplantation genetic screeneing) /PGD (preimplantation genetic diagnosis)

Trial locations and contacts

3 sites in 1 country.

Russia3 sites

AltraVita IVF clinic
Moscow
Perinatal Medical Center
Moscow
Clinical Hospital Lapino
Moscow Oblast

Other trials in Russia

About this study

Official title: Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI

Conditions: Infertility, Female
Being tested: Follitropin alfa (Gonal-f), Follitropin alfa (Primapur)
Keywords: in vitro fertilization
Medical subject headings: Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Follitropin alfa (Gonal-f)Drug
Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Follitropin alfa (Primapur)Drug
Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation

Study groups in NCT03088137
Study group	Role	What they receive
Primapur (Follitropin alfa)	Experimental	Not described Receives: Drug: Follitropin alfa (Primapur)
Gonal-f (Follitropin alfa)	Active comparator	Not described Receives: Drug: Follitropin alfa (Gonal-f)

What is being measured

The primary outcome is the main question the study is designed to answer.

Oocytes (Intention-to-Treat, ITT)
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.
Measured: From date of randomization up to 18 days

Secondary outcomes (11)

Number of Follicles With Size ≥ 16 mm
The number of follicles 16 mm or over in diameter at the day of hCG (or GnRH-agonist) administration
Measured: From date of randomization up to 16 days
Mature Oocytes
The number of mature oocytes (MII stage of development)
Measured: From date of randomization up to 18 days
Fertilised Oocytes
The number of fertilised oocytes with the presence of two pronuclei: 2PN
Measured: From date of randomization up to 19 days
Percentage of Patients With Embryo Transfer
The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up
Measured: From date of randomization up to 25 days
Total Dose of Follitropin Alfa
The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU)
Measured: From date of randomization up to 16 days
Number of Days of Follitropin Alfa Treatment
The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation)
Measured: From date of randomization up to 16 days
Number of Patients With Follitropin Alfa Dose Correction
The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU)
Measured: From date of randomization up to 16 days
Number of Patients With Cycle Cancellation
The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation)
Measured: From date of randomization up to 16 days
Number of No-responders
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)
Measured: From date of randomization up to 8 days
Percentage of Patients With Serum hCG More Than 25 IU/l
Biochemical pregnancy test: serum hCG more than 25 IU/l (days 12-17 after embryo transfer)
Measured: From date of randomization up to 42 days
Percentage of Patients With the Evidence for Clinical Pregnancy
Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity
Measured: The 10th week after embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 201717 Aug 2018

First posted23 Mar 2017
Study start8 Feb 2017
Primary completion17 Aug 2018
Study completion17 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Infertility, FemaleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03088137
Sponsor's protocol ID: FSG-03-01
Status last verified: Mar 2022
First submitted: 2 Mar 2017
Last updated: 1 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

M. Polzikov, Z. Barakhoeva, S. Yakovenko, M. Ovchinnikova, L.Vovk, Y. Fetisova. A multicenter, randomized study comparing the efficacy of follitropin alpha biosimilar and the original follitropin alpha. Abstracts of the 35th Annual Meeting of the ESHRE, Vienna, Austria 24 to 26 June 2019 (abstract P-649), Human Reproduction, 2019; Vol. 34, Suppl. 1, p. i439.
Barakhoeva Z, Vovk L, Fetisova Y, Marilova N, Ovchinnikova M, Tischenko M, Scherbatyuk Y, Kolotovkina A, Miskun A, Kasyanova G, Teterina T, Zorina I, Belousova N, Morozova E, Yakovenko S, Apryshko V, Sichinava L, Shalinsmall a, Cyrillic R, Polzikov M. A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:6-12. doi: 10.1016/j.ejogrb.2019.07.032. Epub 2019 Jul 26.
PubMed 31400644
Barakhoeva Z.B., Vovk L.A., Zorina I.V., Belousova N.Y., Teterina T.A., Yakovenko S.A., Apryshko V.P., Fetisova Y.A., Marilova N.A., Morozova E.G., Ovchinnikova M.M., Tishenko M.A., Sherbatyuk Y.V., Kolotovkina A.V., Miskun A.A., Kasyanova G.V., Sichinava L.G., Shalinа R.I., Polzikov M.A. Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®). Akusherstvo, ginekologiya i reprodukciya. 2018;12(3):5-16. (In Russ.) https://doi.org/10.17749/2313-7347.2018.12.3.005-016
Polzikov M, Blinov D, Barakhoeva Z, Vovk L, Fetisova Y, Ovchinnikova M, Tischenko M, Zorina I, Yurasov V, Ushakova T, Sergeyev O. Association of the Serum Folate and Total Calcium and Magnesium Levels Before Ovarian Stimulation With Outcomes of Fresh In Vitro Fertilization Cycles in Normogonadotropic Women. Front Endocrinol (Lausanne). 2022 Feb 11;13:732731. doi: 10.3389/fendo.2022.732731. eCollection 2022.
PubMed 35222266

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
ClinicalTrials.gov ID: NCT03088137
Acronym / sponsor ID: FSG-03-01
Conditions: Infertility, Female
Keywords: in vitro fertilization
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: IVFarma LLCIndustry (pharma, biotech, devices)
Collaborators: BridgePharm LLC, GlobalPharma LLC
Study start: 8 Feb 2017 (actual)
Primary completion: 17 Aug 2018 (actual)
Study completion: 17 Aug 2018 (actual)
First posted: 23 Mar 2017 (actual)
Results: Posted 6 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Primapur (Follitropin alfa)	Experimental	Drug: Follitropin alfa (Primapur)
Gonal-f (Follitropin alfa)	Active comparator	Drug: Follitropin alfa (Gonal-f)

Who may qualify

Ages: 20 to 35 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Infertility due to tubal factor and/or male factor
Age between 20 and 35 years with regular menstrual cycles of 21-35 days
First or second cycle in the present series of ART
BMI (body mass index) ≥ 18 ≤ 30 kg/m2
Basal FSH (follicle stimulating hormone) < 10 IU/L (cycle day 2-5)

Key exclusion criteria (19 listed)

Presence of pregnancy
Hypersensitivity to follitropin alfa
Ovarian cysts
History of ≥2 succeeding ART (assisted reproductive technology) cycles IVF (in vitro fertilization) and/or ICSI (Intracytoplasmic sperm injection) before the study cycle
Previous history of severe ovarian hyperstimulation syndrome

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Follitropin alfa (Gonal-f)Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Drug	Gonal-f (Follitropin alfa)
Follitropin alfa (Primapur)Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation	Drug	Primapur (Follitropin alfa)

Primary outcome

Oocytes (Intention-to-Treat, ITT)
Time frame: 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.

11 secondary outcomes

Number of Follicles With Size ≥ 16 mm
Time frame: From date of randomization up to 16 days
Mature Oocytes
Time frame: From date of randomization up to 18 days
Fertilised Oocytes
Time frame: From date of randomization up to 19 days
Percentage of Patients With Embryo Transfer
Time frame: From date of randomization up to 25 days
Total Dose of Follitropin Alfa
Time frame: From date of randomization up to 16 days
Number of Days of Follitropin Alfa Treatment
Time frame: From date of randomization up to 16 days
Number of Patients With Follitropin Alfa Dose Correction
Time frame: From date of randomization up to 16 days
Number of Patients With Cycle Cancellation
Time frame: From date of randomization up to 16 days
Number of No-responders
Time frame: From date of randomization up to 8 days
Percentage of Patients With Serum hCG More Than 25 IU/l
Time frame: From date of randomization up to 42 days
Percentage of Patients With the Evidence for Clinical Pregnancy
Time frame: The 10th week after embryo transfer

Results and safety

Results posted to the registry on 6 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primapur (Follitropin Alfa)	55	55
Gonal-f (Follitropin Alfa)	55	55

Primary outcome: Oocytes (Intention-to-Treat, ITT)

Time frame: From date of randomization up to 18 days. Mean (Standard Deviation). Unit: Number of retrieved oocytes

Measure	Primapur (Follitropin Alfa) n = 55	Gonal-f (Follitropin Alfa) n = 55
Value	12.16 (7.28)	11.62 (6.29)

Primapur (Follitropin Alfa) vs Gonal-f (Follitropin Alfa): Mean Difference (Final Values): 0.546 (95% CI -2.026 to 3.116), p = 0.002, Wilcoxon (Mann-Whitney)

Population analysed: Intention-to-Treat

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year, 6 month. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primapur (Follitropin Alfa)	2 of 55 (3.6%)	21 of 55 (38.2%)	0 of 55
Gonal-f (Follitropin Alfa)	2 of 55 (3.6%)	13 of 55 (23.6%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationM. Polzikov, Z. Barakhoeva, S. Yakovenko, M. Ovchinnikova, L.Vovk, Y. Fetisova. A multicenter, randomized study comparing the efficacy of follitropin alpha biosimilar and the original follitropin alpha. Abstracts of the 35th Annual Meeting of the ESHRE, Vienna, Austria 24 to 26 June 2019 (abstract P-649), Human Reproduction, 2019; Vol. 34, Suppl. 1, p. i439.
Results publication: PubMed 31400644Barakhoeva Z, Vovk L, Fetisova Y, Marilova N, Ovchinnikova M, Tischenko M, Scherbatyuk Y, Kolotovkina A, Miskun A, Kasyanova G, Teterina T, Zorina I, Belousova N, Morozova E, Yakovenko S, Apryshko V, Sichinava L, Shalinsmall a, Cyrillic R, Polzikov M. A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:6-12. doi: 10.1016/j.ejogrb.2019.07.032. Epub 2019 Jul 26.
Results publicationBarakhoeva Z.B., Vovk L.A., Zorina I.V., Belousova N.Y., Teterina T.A., Yakovenko S.A., Apryshko V.P., Fetisova Y.A., Marilova N.A., Morozova E.G., Ovchinnikova M.M., Tishenko M.A., Sherbatyuk Y.V., Kolotovkina A.V., Miskun A.A., Kasyanova G.V., Sichinava L.G., Shalinа R.I., Polzikov M.A. Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®). Akusherstvo, ginekologiya i reprodukciya. 2018;12(3):5-16. (In Russ.) https://doi.org/10.17749/2313-7347.2018.12.3.005-016
Derived from this study: PubMed 35222266Polzikov M, Blinov D, Barakhoeva Z, Vovk L, Fetisova Y, Ovchinnikova M, Tischenko M, Zorina I, Yurasov V, Ushakova T, Sergeyev O. Association of the Serum Folate and Total Calcium and Magnesium Levels Before Ovarian Stimulation With Outcomes of Fresh In Vitro Fertilization Cycles in Normogonadotropic Women. Front Endocrinol (Lausanne). 2022 Feb 11;13:732731. doi: 10.3389/fendo.2022.732731. eCollection 2022.
European Journal of Obstetrics \& Gynecology and Reproductive Biology Volume 241, October 2019, Pages 6-12Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Follitropin alfa (Gonal-f) and Follitropin alfa (Primapur) in people with Infertility, Female, run by IVFarma LLC at 3 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oocytes (Intention-to-Treat, ITT) (time frame: From date of randomization up to 18 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03088137, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.