Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04605107
Other study ID # GRC/1/13/433
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 30, 2013
Est. completion date March 8, 2015

Study information

Verified date September 2020
Source Genuine Research Center, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Ampoules (EIPICO PHARMA, EGYPT) and Treatment B REFERENCE Product Pregnyl 5000 I.U. Ampoules (Baxter Pharmaceutical Solutions for Organon, USA)


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 8, 2015
Est. primary completion date January 8, 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: 1. Premenopausal woman between 18 - 40 years of age. 2. Body mass index (BMI) of 32 or less. 3. A menstrual cycle lasting between 21 and 35 days. 4. 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 5. Patient having both ovaries and a normal uterine cavity confirmed by hysteroscopy, or hysterosalpingography. 6. 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 7. Patients achieving good ovarian response and considered to receive hCG for final follicular maturation prior to OPU. 8. Written and signed informed consent by the patient. 9. Subject does not have allergy to the drugs under investigation. 10. Medical demographics without evidence of clinically significant deviation from rather normal medical condition. Exclusion Criteria: 1. Patients with low ovarian reserve, as proved by hormonal assays and basal antral follicular count. 2. More than three previous assisted reproductive technology cycle or treatment with clomiphene citrate or gonadotropins for at least 1 month before screening, 3. Patients with pelvic abnormality that would interfere with ovarian accessibility for OPU, e.g. ovarian endometriotic cysts or high and retro-uterine ovary. 4. 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. 5. History of hypersensitivity to the study medications or to drugs with similar chemical structure. 6. 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. 7. Mental condition rendering the patients unable to understand the nature, scope and possible consequences of the study. 8. Results of laboratory tests which are clinically significant. 9. Acute infection within one week preceding first study drug administration. 10. History of drug or alcohol abuse. 11. 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. 12. Subject is on a special diet (for example subject is vegetarian). 13. 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. 14. 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. 15. Subject has a history of severe diseases which have direct impact on the study. 16. Participation in a biosimilarity study or in a clinical study within the last 6 weeks before first study drug administration. 17. Subject intends to be hospitalized within 3 months after first study drug administration.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Epifasi: Human chorionic gonadotrophin
IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin
Pregnyl: Human chorionic gonadotrophin
IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin

Locations

Country Name City State
Egypt Genuine Research Center GRC Cairo

Sponsors (2)

Lead Sponsor Collaborator
Genuine Research Center, Egypt EIPICO PHARMA, EGYPT

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Driscoll 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. — View Citation

Schuirmann 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. — View Citation

Steinijans VW, Diletti E. Statistical analysis of bioavailability studies: parametric and nonparametric confidence intervals. Eur J Clin Pharmacol. 1983;24(1):127-36. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 34-36 hours post dose
Secondary Safety Evaluation Any reported adverse effect from the patient side or observed by the investigator, Also any abnormal lab finding. the patient is observed during the whole course of the study and for one month post study
See also
  Status Clinical Trial Phase
Recruiting NCT05969574 - Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Recruiting NCT05358483 - PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Completed NCT03177538 - Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders Phase 4
Completed NCT03638856 - Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy N/A
Completed NCT04052464 - The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Withdrawn NCT04753736 - Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC N/A
Completed NCT03349905 - Deferred Versus Fresh Embryo Transfers N/A
Completed NCT05076981 - Progesterone Levels During Ovulation and Luteal Phase
Completed NCT04096027 - Cabergoline Before or After Oocyte Collection for Follicular Resolution Phase 4
Recruiting NCT05980091 - Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration. Phase 1
Terminated NCT01933633 - Improved Fertility After Exercise in Overweight/Obese Women N/A
Completed NCT01202656 - Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization) Phase 1/Phase 2
Terminated NCT01202643 - Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF Phase 1/Phase 2
Completed NCT01408615 - A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
Enrolling by invitation NCT05698550 - The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET Phase 3
Not yet recruiting NCT03910582 - Personalized FET in RIF Patients With Displaced Dating N/A
Completed NCT05440019 - Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
Completed NCT05130125 - Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer