Infertility, FemalePhase 4NCT04605107
Biosimilarity Study of IM Injection of Human Chorionic Gonadotrophin After Parenteral Administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA).
A Phase 4 study testing Epifasi: Human chorionic gonadotrophin and Pregnyl: Human chorionic gonadotrophin in people with Infertility, Female, run by Genuine Research Center, Egypt at 1 site in Egypt.
Trial summary
Comparative randomized, single dose, parallel, triple-blinded study in infertile females to evaluate biosimilarity of IM Injection of Human Chorionic Gonadotrophin (HCG) after Parenteral administration of Treatment A TEST Product Epifasi 5000 I.U. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Epifasi: Human chorionic gonadotrophin and Pregnyl: Human chorionic gonadotrophin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2013to 8 Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal woman between 18 - 40 years of age.
- Body mass index (BMI) of 32 or less.
- A menstrual cycle lasting between 21 and 35 days.
- Serum hormone levels of FSH 12 IU/L or less, PRL 1040 mIU/L or less, and TSH within the normal range of 0.3- 4.9 mIU/L
- Patient having both ovaries and a normal uterine cavity confirmed by hysteroscopy, or hysterosalpingography.
- All patients had to be infertile due to at least one of the following causes and must have justified ART (Assisted Reproductive Technology) treatment: tubal factor, mild endometriosis (American Fertility Society classification stage I orII), unexplained infertility, or male factor
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- Patients achieving good ovarian response and considered to receive hCG for final follicular maturation prior to OPU.
- Written and signed informed consent by the patient.
- Subject does not have allergy to the drugs under investigation.
- Medical demographics without evidence of clinically significant deviation from rather normal medical condition.
Who cannot join
- Patients with low ovarian reserve, as proved by hormonal assays and basal antral follicular count.
- More than three previous assisted reproductive technology cycle or treatment with clomiphene citrate or gonadotropins for at least 1 month before screening,
- Patients with pelvic abnormality that would interfere with ovarian accessibility for OPU, e.g. ovarian endometriotic cysts or high and retro-uterine ovary.
- Patients not achieving a satisfactory ovarian response on ovulation induction, whether poor response (3 or less mature ovarian follicles) or over-response with high likelihood of developing ovarian hyperstimulation syndrome (OHSS) on triggering with HCG.
- History of hypersensitivity to the study medications or to drugs with similar chemical structure.
- Patients unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and likelihood of not completing the study.
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- Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study.
- Results of laboratory tests which are clinically significant.
- Acute infection within one week preceding first study drug administration.
- History of drug or alcohol abuse.
- Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
- Subject is on a special diet (for example subject is vegetarian).
- Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
- Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
- Subject has a history of severe diseases which have direct impact on the study.
- Participation in a biosimilarity study or in a clinical study within the last 6 weeks before first study drug administration.
- Subject intends to be hospitalized within 3 months after first study drug administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Randomized, Single Dose, Parallel, Triple-blinded Study in Infertile Females to Evaluate Biosimilarity of IM Injection of Human Chorionic Gonadotrophin After Parenteral Administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA)
Comparative randomized, single dose, parallel, triple-blinded study in infertile females to evaluate biosimilarity of IM Injection of Human Chorionic Gonadotrophin (HCG) after Parenteral administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA)
Read the detailed description
In this study, the biosimilarity of Human chorionic gonadotropin (HCG) from Epifasi IM Injection (EIPICO Pharma Egypt) and Pregnyl IM Injection (Baxter Pharmaceutical Solutions for Organon, USA) after a single IM dose administration of each to healthy adult will be investigated to determining the study variables: Ovarian Ultrasonic counting mature grafian follicles, Number of retrieved oocytes and their grades.
- Conditions
- Infertility, Female
- Being tested
- Epifasi: Human chorionic gonadotrophin, Pregnyl: Human chorionic gonadotrophin
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epifasi: Human chorionic gonadotrophinDrug
Also called Epifasi
IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin
Pregnyl: Human chorionic gonadotrophinDrug
Also called Pregnyl
IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin
| Study group | Role | What they receive |
|---|---|---|
| A test | Experimental | Epifasi 5000 I.U. Ampoules Receives: Drug: Epifasi: Human chorionic gonadotrophin |
| B reference | Active comparator | Pregnyl 5000 I.U. Ampoules Receives: Drug: Pregnyl: Human chorionic gonadotrophin |
What is being measured
The primary outcome is the main question the study is designed to answer.
No. of mature follicles
A dose of Epifasi 5000 I.U. Ampoule was injected to trigger ovulation., At least, one mature follicle should be detected with a diameter of 18 mm or more \& two additional follicles reached a diameter of 16 mm or more. 34 to 36 hours later oocytes were retrieved.
Measured: Up to 34-36 hours post dose
Secondary outcomes (1)
Safety Evaluation
Any reported adverse effect from the patient side or observed by the investigator, Also any abnormal lab finding.
Measured: the patient is observed during the whole course of the study and for one month post study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start30 Aug 2013
- Primary completion8 Jan 2015
- Study completion8 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genuine Research Center, Egypt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EIPICO PHARMA, EGYPT
- Responsible party
- Sponsor
- Investigators
- Ahmed Elshafeey, Ph.D. Pharma, Study director, Genuine Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605107
- Sponsor's protocol ID
- GRC/1/13/433
- Status last verified
- Sep 2020
- First submitted
- 22 Sep 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steinijans VW, Diletti E. Statistical analysis of bioavailability studies: parametric and nonparametric confidence intervals. Eur J Clin Pharmacol. 1983;24(1):127-36. doi: 10.1007/BF00613939.
PubMed 6832195Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
PubMed 3450848Driscoll GL, Tyler JP, Hangan JT, Fisher PR, Birdsall MA, Knight DC. A prospective, randomized, controlled, double-blind, double-dummy comparison of recombinant and urinary HCG for inducing oocyte maturation and follicular luteinization in ovarian stimulation. Hum Reprod. 2000 Jun;15(6):1305-10. doi: 10.1093/humrep/15.6.1305.
PubMed 10831560
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Randomized, Single Dose, Parallel, Triple-blinded Study in Infertile Females to Evaluate Biosimilarity of IM Injection of Human Chorionic Gonadotrophin After Parenteral Administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA)
- ClinicalTrials.gov ID
- NCT04605107
- Acronym / sponsor ID
- GRC/1/13/433
- Conditions
- Infertility, Female
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Genuine Research Center, EgyptIndustry (pharma, biotech, devices)
- Collaborators
- EIPICO PHARMA, EGYPT
- Study start
- 30 Aug 2013 (actual)
- Primary completion
- 8 Jan 2015 (actual)
- Study completion
- 8 Mar 2015 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparative randomized, single dose, parallel, triple-blinded study in infertile females to evaluate biosimilarity of IM Injection of Human Chorionic Gonadotrophin (HCG) after Parenteral administration of Treatment A TEST Product Epifasi 5000 I.U. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA)
Detailed description
In this study, the biosimilarity of Human chorionic gonadotropin (HCG) from Epifasi IM Injection (EIPICO Pharma Egypt) and Pregnyl IM Injection (Baxter Pharmaceutical Solutions for Organon, USA) after a single IM dose administration of each to healthy adult will be investigated to determining the study variables: Ovarian Ultrasonic counting mature grafian follicles, Number of retrieved oocytes and their grades.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A test | Experimental | Drug: Epifasi: Human chorionic gonadotrophinEpifasi 5000 I.U. Ampoules |
| B reference | Active comparator | Drug: Pregnyl: Human chorionic gonadotrophinPregnyl 5000 I.U. Ampoules |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Premenopausal woman between 18 - 40 years of age.
- Body mass index (BMI) of 32 or less.
- A menstrual cycle lasting between 21 and 35 days.
- Serum hormone levels of FSH 12 IU/L or less, PRL 1040 mIU/L or less, and TSH within the normal range of 0.3- 4.9 mIU/L
- Patient having both ovaries and a normal uterine cavity confirmed by hysteroscopy, or hysterosalpingography.
Key exclusion criteria (17 listed)
- Patients with low ovarian reserve, as proved by hormonal assays and basal antral follicular count.
- More than three previous assisted reproductive technology cycle or treatment with clomiphene citrate or gonadotropins for at least 1 month before screening,
- Patients with pelvic abnormality that would interfere with ovarian accessibility for OPU, e.g. ovarian endometriotic cysts or high and retro-uterine ovary.
- Patients not achieving a satisfactory ovarian response on ovulation induction, whether poor response (3 or less mature ovarian follicles) or over-response with high likelihood of developing ovarian hyperstimulation syndrome (OHSS) on triggering with HCG.
- History of hypersensitivity to the study medications or to drugs with similar chemical structure.
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 |
|---|---|---|
| Epifasi: Human chorionic gonadotrophinAlso: EpifasiIM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin | Drug | A test |
| Pregnyl: Human chorionic gonadotrophinAlso: PregnylIM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin | Drug | B reference |
Primary outcome
No. of mature follicles
Time frame: Up to 34-36 hours post dose
A dose of Epifasi 5000 I.U. Ampoule was injected to trigger ovulation., At least, one mature follicle should be detected with a diameter of 18 mm or more \& two additional follicles reached a diameter of 16 mm or more. 34 to 36 hours later oocytes were retrieved.
1 secondary outcome
Safety Evaluation
Time frame: the patient is observed during the whole course of the study and for one month post study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Background: PubMed 6832195Steinijans VW, Diletti E. Statistical analysis of bioavailability studies: parametric and nonparametric confidence intervals. Eur J Clin Pharmacol. 1983;24(1):127-36. doi: 10.1007/BF00613939.
- Background: PubMed 3450848Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.
- Background: PubMed 10831560Driscoll GL, Tyler JP, Hangan JT, Fisher PR, Birdsall MA, Knight DC. A prospective, randomized, controlled, double-blind, double-dummy comparison of recombinant and urinary HCG for inducing oocyte maturation and follicular luteinization in ovarian stimulation. Hum Reprod. 2000 Jun;15(6):1305-10. doi: 10.1093/humrep/15.6.1305.
- International conference of harmonization of technical requirements for registration of pharmaceuticals for human use. ICH harmonized tripartite guideline. Guidelines for good clinical practice. May 1996.Link provided by the sponsor.
- The European Agency for the Evaluation of Medicinal products (EMEA). Note for guidance on good clinical practice (CPMP/ICH/135/95), May 1997.Link provided by the sponsor.
- Guidance for Industry: Bioavailability and Bioequivalence studies for orally administered drug products-general considerations. US Dept. of Health and Human Services, food and drug administration (FDA), center for drug evaluation and research (CDER), MLink 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.
Ahmed Elshafeey, Ph.D. Pharma study director
Genuine Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epifasi: Human chorionic gonadotrophin and Pregnyl: Human chorionic gonadotrophin in people with Infertility, Female, run by Genuine Research Center, Egypt at 1 site in Egypt.
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 17 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 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
No. of mature follicles (time frame: Up to 34-36 hours post dose). 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 NCT04605107, which also lists 3 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 27 Oct 2020.