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The purpose of the study is to evaluate the clinical equivalence and the general tolerability of two different subcutaneous hCG preparations (hCG-IBSA, IBSA vs Ovitrelle, Serono) when administered to patients undergoing IVF.
This is a prospective, multicenter, randomized, investigator blind, parallel group, active control, phase III clinical trial. Patients meeting the eligibility requirements of the study will be randomly assigned to receive either the test drug (hCG-IBSA, IBSA) or the reference drug (Ovitrelle, Serono). Investigators will be blinded by not allowing them to have any contact with the study medications (supplied in boxes labeled in a manner that does not reveal the content of the boxes), and requesting that patients do not make any statements to the investigator that might indicate the treatment to which they were assigned. Equivalence testing with regard to the primary outcome variable will establish whether the two treatments are indeed similarly effective.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hCG-IBSA | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of oocytes retrieved per patient who received hCG |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who received hCG with at least one oocyte retrieved, 2PN fertilized oocytes, | ||
| 2PN or cleaved embryos, implantation rate per embryo transferred; Serum P and hCG concentration on the days of oocyte retrieval, on day of embryo transfer and on day 5-8 post-hCG; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique de Ziegler, Prof. | Départements de Gynécologie/Obstétrique et de Pédiatrie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gynecology and Obstetrics Universitätfrauenklinik | Basel | 4031 | Switzerland | |||
| 4. Department of Gynecology and Obstetrics Frauenklinik, InselspitalEffingerstrasse 102 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6267989 | Background | Pierce JG, Parsons TF. Glycoprotein hormones: structure and function. Annu Rev Biochem. 1981;50:465-95. doi: 10.1146/annurev.bi.50.070181.002341. No abstract available. | |
| 6012569 | Background | Johnsen SG. A study of human testicular function by the use of human menopausal gonadotrophin and of human chorionic gonadotrophin in male hypogonadotrophic eunuchoidism and infantilism. Acta Endocrinol (Copenh). 1966 Oct;53(2):315-41. doi: 10.1530/acta.0.0530315. No abstract available. |
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| Implantation rate;Pregnancy rate. |
| Adverse Events | Adverse events were monitored and collected during all the study period | from day 1 to 35 +/- 7 days after oocytes retrieval |
| Incidence of moderate or severe OHSS | The incidence moderate or severe of OHSS will be assessed in both treatment groups | From the day of hCG injection until 35 +/- 7 days after oocyte retrieval |
| Bern |
| 3010 |
| Switzerland |
| Department of Gynecology and ObstetricsUniversity Hospital | Geneva | 1211 | Switzerland |
| 3. Maternity CHUV - Centre Hospitalier Universitaire Vaudois | Lausanne | 1011 | Switzerland |
| 6105640 | Background | Forest MG, David M, Lecoq A, Jeune M, Bertrans J. Kinetics of the HCG-induced steroidogenic response of the human testis. III. Studies in children of the plasma levels of testosterone and HCG: rationale for testicular stimulation test. Pediatr Res. 1980 Jun;14(6):819-24. doi: 10.1203/00006450-198006000-00009. |
| 14321057 | Background | GEMZELL C. INDUCTION OF OVULATION WITH HUMAN GONADOTROPINS. Recent Prog Horm Res. 1965;21:179-204. No abstract available. |
| 1868645 | Background | Fleischer AC. Transabdominal and transvaginal sonography of ovarian masses. Clin Obstet Gynecol. 1991 Jun;34(2):433-42. doi: 10.1097/00003081-199106000-00027. |
| 3122575 | Background | Vermesh M, Kletzky OA. Follicle-stimulating hormone is the main determinant of follicular recruitment and development in ovulation induction with human menopausal gonadotropin. Am J Obstet Gynecol. 1987 Dec;157(6):1397-402. doi: 10.1016/s0002-9378(87)80231-4. |
| 5778792 | Background | Brown JB, Evans JH, Adey FD, Taft HP, Townsend L. Factors involved in the induction of fertile ovulation with human gonadotrophins. J Obstet Gynaecol Br Commonw. 1969 Apr;76(4):289-307. doi: 10.1111/j.1471-0528.1969.tb05837.x. No abstract available. |
| 6419189 | Background | Venturoli S, Paradisi R, Fabbri R, Magrini O, Porcu E, Flamigni C. Comparison between human urinary follicle-stimulating hormone and human menopausal gonadotropin treatment in polycystic ovary. Obstet Gynecol. 1984 Jan;63(1):6-11. |
| 3119376 | Background | Abdalla HI, Ah-Moye M, Brinsden P, Howe DL, Okonofua F, Craft I. The effect of the dose of human chorionic gonadotropin and the type of gonadotropin stimulation on oocyte recovery rates in an in vitro fertilization program. Fertil Steril. 1987 Dec;48(6):958-63. doi: 10.1016/s0015-0282(16)59591-0. |
| 2660037 | Background | Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E. Ovarian hyperstimulation syndrome: an update review. Obstet Gynecol Surv. 1989 Jun;44(6):430-40. doi: 10.1097/00006254-198906000-00004. No abstract available. |
| 9990695 | Background | Hauschke D, Kieser M, Diletti E, Burke M. Sample size determination for proving equivalence based on the ratio of two means for normally distributed data. Stat Med. 1999 Jan 15;18(1):93-105. doi: 10.1002/(sici)1097-0258(19990115)18:13.0.co;2-8. |
| 23116325 | Derived | Bellavia M, de Geyter C, Streuli I, Ibecheole V, Birkhauser MH, Cometti BP, de Ziegler D. Randomized controlled trial comparing highly purified (HP-hCG) and recombinant hCG (r-hCG) for triggering ovulation in ART. Gynecol Endocrinol. 2013 Feb;29(2):93-7. doi: 10.3109/09513590.2012.730577. Epub 2012 Nov 2. |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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