Infertility, Female Clinical Trial
Official title:
Multicentre Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Verified date | March 2022 |
Source | IVFarma LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 118 |
Est. completion date | August 17, 2018 |
Est. primary completion date | August 17, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility | Inclusion Criteria: - 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) - 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 Exclusion Criteria: - 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) - 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) |
Country | Name | City | State |
---|---|---|---|
Russian Federation | AltraVita IVF clinic | Moscow | |
Russian Federation | Perinatal Medical Center | Moscow | |
Russian Federation | Clinical Hospital Lapino | Moscow Oblast |
Lead Sponsor | Collaborator |
---|---|
IVFarma LLC | BridgePharm LLC, GlobalPharma LLC |
Russian Federation,
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, Shalin? R, Polzikov M. A multicenter, rand — View Citation
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
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, V
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From date of randomization up to 18 days | |
Secondary | 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 | From date of randomization up to 16 days | |
Secondary | Mature Oocytes | The number of mature oocytes (MII stage of development) | From date of randomization up to 18 days | |
Secondary | Fertilised Oocytes | The number of fertilised oocytes with the presence of two pronuclei: 2PN | From date of randomization up to 19 days | |
Secondary | Percentage of Patients With Embryo Transfer | The number of patients (and percentage) with embryo transfers on days 3 and 5 after ovum pick-up | From date of randomization up to 25 days | |
Secondary | Total Dose of Follitropin Alfa | The total dose of the follitropin alfa administrated during the ovarian hyperstimulation protocol (measured in International Units - IU) | From date of randomization up to 16 days | |
Secondary | Number of Days of Follitropin Alfa Treatment | The duration of ovarian hyperstimulation protocol (at the day of trigger of ovulation) | From date of randomization up to 16 days | |
Secondary | Number of Patients With Follitropin Alfa Dose Correction | The number of dose adjustments during the ovarian hyperstimulation protocol (increment 25-50 IU) | From date of randomization up to 16 days | |
Secondary | Number of Patients With Cycle Cancellation | The number of the ovarian hyperstimulation protocol cancellation (at the day of trigger of ovulation) | From date of randomization up to 16 days | |
Secondary | 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) | From date of randomization up to 8 days | |
Secondary | 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) | From date of randomization up to 42 days | |
Secondary | Percentage of Patients With the Evidence for Clinical Pregnancy | Confirmation of clinical pregnancy: ultrasound detection of intrauterine gestational sac and heart activity | The 10th week after embryo transfer |
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 | |
Terminated |
NCT01202643 -
Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF
|
Phase 1/Phase 2 | |
Completed |
NCT01202656 -
Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)
|
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
|