#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Comparison of vaginal use of micronized progesterone for the luteal support.
Randomized study comparison of Utrogestan and Crinone 8%


Authors: L. Michnová 1;  J. Dostál 2;  K. Langová 3;  T. Rumpíková 4;  M. Kudela 2
Authors‘ workplace: IVF Clinic, Olomouc, vedoucí lékař MUDr. Š. Machač, Ph. D. 1;  Porodnicko-gynekologická klinika FN a LF UP, Olomouc, přednosta prof. MUDr. R. Pilka, Ph. D. 2;  Ústav lékařské biofyziky FN a LF UP, Olomouc, přednostka prof. RNDr. H. Kolářová, CSc. 3;  Klinika reprodukční medicíny a gynekologie IVF, Zlín, odborný zástupce a ředitel kliniky MUDr. D. Rumpík 4
Published in: Ceska Gynekol 2017; 82(1): 28-37

Overview

Objective:
The study was focused on comparison of efficiency, safety and tolerance of vaginal use of micronized progesterone in preparations Utrogestan and Crinone 8%.

Design:
Prospective randomized study.

Setting:
Department of Gynecology and Obstetric, University Hospital, Olomouc, Faculty of Medicine and Dentistry, Palacky University, Olomouc.

Material and methodology:
Into a prospective randomized study was, after calculation of 80% of the power of the study, α = 0,05, included 111 women in age between 18–40 with a basal value FSH < 10 IU/l and a normal finding in uteral cavity. After evaluation of efficiency of both preparations there was selected a fertilization rate, an implantation rate, a pregnancy rate and a take-home baby rate. Comparison of tolerance was made from evaluation of 21 parameters which were obtained through a questionnaire.

Results:
There were not been proven any significant differences in efficiency between both preparations. Crinone 8% was in patients better tolerated.

Conclusion:
Luteal support within the IVF/ICSI-ET remains an integral part of the treatment. According to the outcomes of the study it seems to be more suitable to use a vaginal gel for the luteal support with micronized progesterone.

Keywords:
luteal phase support, IVF/ET


Sources

1. Anthony, FW., Smith, EM., Gadd, SC., et al. Placental protein 14 secretion during in vitro fertilization cycles with and without human chorionic gonadotropin for luteal support. Fertil Steril, 1993, 59, 1, p. 187–191.

2. Araujo, E. Jr., Bernardini, L., Frederick, JL., et al. Prospective randomized comparison of human chorionic gonadotropin versus intramuscular progesterone for luteal-phase support in assisted reproduction. J Assist Reprod Genet, 1994, 11, 2, p. 74–78.

3. Beckers, NG., Laven, JS., Eijkemans, MJ., Fauser, BC. Follicular and luteal phase characteristics following early cessation of gonadotrophin-releasing hormone agonist during ovarian stimulation for in-vitro fertilization. Hum Reprod, 2000, 15, 1, p. 43–49.

4. Beckers, NG., Macklon, NS., Eijkemans, MJ., et al. Nonsupplemented luteal phase characteristics after the administration of recombinant human chorionic gonadotropin, recombinant luteinizing hormone, or gonadotropin-releasing hormone (GnRH) agonist to induce final oocyte maturation in in vitro fertilization patients after ovarian stimulation with recombinant follicle-stimulating hormone and GnRH antagonist cotreatment. J Clin Endocrinol Metab, 2003, 88, 9, p. 4186–4192.

5. Beckers, NG., Platteau, P., Eijkemans, MJ., et al. The early luteal phase administration of estrogen and progesterone does not induce premature luteolysis in normo-ovulatory women. Eur J Endocrinol, 2006, 155, 2, p. 355–363.

6. Bouckaert, Y., Robert, F., Englert, Y., et al. Acute eosinophilic pneumonia associated with intramuscular administration of progesterone as luteal phase support after IVF: case report. Hum Reprod, 2004, 19, 8, p. 1806–1810.

7. Bourgain, C., Devroey, P., Van Waesberghe, L., et al. Effects of natural progesterone on the morphology of the endometrium in patients with primary ovarian failure. Hum Reprod, 1990, 5, 5, p. 537–543.

8. Cicinelli, E., de Ziegler, D., Bulletti, C., et al. Direct transport of progesterone from vagina to uterus. Obstet Gynecol, 2000, 95, 3, p. 403–406.

9. Csapo, AI., Pulkkinen, MO., Ruttner, B., et al. The significance of the human corpus luteum in pregnancy maintenance. I. Preliminary studies. Am J Obstet Gynecol, 1972, 112, 8, p. 1061–1067.

10. Csapo, AI., Pulkkinen, MO., Wiest, WG. Effects of luteectomy and progesterone replacement therapy in early pregnant patients. Am J Obstet Gynecol, 1973, 115, 6, p. 759–765.

11. de Ziegler, D., Seidler, L., Schärer, E., et al. Non-oral administration of progesterone: experiences and possibilities of the transvaginal route. Praxis, 1995, 84, 5, p. 127–133.

12. Devoto, L., Vega, M., Kohen, P., et al. Endocrine and paracrine-autocrine regulation of the human corpus luteum during the mid-luteal phase. J Reprod Fertil, 2000, suppl., 55, p. 13–20.

13. Edwards, RG. An introduction to Bourn Hall: the biomedical backround of the Bourn Hall Clinic. In Brinsden, P. (ed.) Textbook of in vitro fertilization and assisted reproduction. 3rd ed. London: Informa Healthcare, 2007, p. 1–7.

14. Edwards, RG., Steptoe, PC., Purdy, JM. Establishing full-term human pregnancies using cleaving embryos grown in vitro. Br J Obstet Gynaecol, 1980, 87, 9, p. 737–756.

15. Farhi, J., Weissman, A., Steinfeld, Z., et al. Estradiol supplementation during the luteal phase may improve the pregnancy rate in patients undergoing in vitro fertilization-embryo transfer cycles. Fertil Steril, 2000, 73, 4, p. 761–766.

16. Fatemi, HM., Popovic-Todorovic, B., Papanikolaou, E., et al. An update of luteal phase support in stimulated IVF cycles. Hum Reprod Update, 2007, 13, 6, p. 581–590.

17. Fauser, BC., Devroey, P. Reproductive biology and IVF: ovarian stimulation and luteal phase consequences. Trends Endocrinol Metab, 2003, 14, 5, p. 236–242.

18. Ghosh, D., Stewart, DR., Nayak, NR., et al. Serum concentrations of oestradiol-17beta, progesterone, relaxin and chorionic gonadotrophin during blastocyst implantation in natural pregnancy cycle and in embryo transfer cycle in the rhesus monkey. Hum Reprod, 1997, 12, 5, p. 914–920.

19. Harper, MJ. The implantation window. Baillieres Clin Obstet Gynaecol, 1992, 6, 2, p. 351–371.

20. Hild-Petito, S., Fazleabas, AT. Expression of steroid receptors and steroidogenic enzymes in the baboon (Papio anubis) corpus luteum during the menstrual cycle and early pregnancy. J Clin Endocrinol Metab, 1997, 82, 3, p. 955–962.

21. Hohmann, FP., Laven, JS., de Jong, FH., et al. Low-dose exogenous FSH initiated during the early, mid or late follicular phase can induce multiple dominant follicle development. Hum Reprod, 2001, 16, 5, p. 846–854.

22. Honda, T., Fujiwara, H., Yamada, S., et al. Integrin alpha5 is expressed on human luteinizing granulosa cells during corpus luteum formation, and its expression is enhanced by human chorionic gonadotrophin in vitro. Mol Hum Reprod, 1997, 3, 11, p. 979–984.

23. Chakravarty, BN., Shirazee, HH., Dam, P., et al. Oral dydrogesterone versus intravaginal micronised progesterone as luteal phase support in assisted reproductive technology (ART) cycles: results of a randomised study. J Steroid Biochem Mol Biol, 2005, 97, 5, p. 416–420.

24. Chan, CC., Ng, EH., Chan, MM., et al. Bioavailability of hCG after intramuscular or subcutaneous injection in obese and non-obese women. Human Reprod, 2003, 18(11), p. 2294–2297.

25. Choavaratana, R., Manoch, D. Efficacy of oral micronized progesterone when applied via vaginal route. J Med Ass Thailand, 2004, 87(5), p. 455–458.

26. Jones, HW. Jr., Jones, GS., Hodgen GD., Rosenwaks, Z. (eds.) IVF-Norfolk. 1st ed. Baltimore: Williams & Wilkins, 1986, 232 p.

27. Kerin, JF., Broom, TJ., Ralph, MM., et al. Human luteal phase function following oocyte aspiration from the immediately preovular graafian follicle of spontaneous ovular cycles. Brit J Obstet Gynaec, 1981, 88(10), p. 1021–1028.

28. Kolibianakis, EM., Venetis, CA., Papanikolaou, EG., et al. Estrogen addition to progesterone for luteal phase support in cycles stimulated with GnRH analogues and gonadotrophins for IVF: a systematic review and meta-analysis. Hum Reprod, 2008, 23, 6, p. 1346–1354.

29. Lejeune, B., Camus, M., Deschacht, J., Leroy, F. Differences in the luteal phases after failed or successful in vitro fertilization and embryo replacement. J In Vitro Fert Embryo Transf, 1986, 3, 6, p. 358–365.

30. Levine, H. Luteal support in IVF using the novel vaginal progesterone gel Crinone 8%: results of an open-label trial in 1184 women from 16 US centers. Fertil Steril, 2000, 74, 4, p. 836–837.

31. Ludwig, M., Schwartz, P., Babahan, B., et al. Luteal phase support using either Crinone 8% or Utrogest: results of a prospective, randomized study. Eur J Obstet Gynecol Reprod Biol, 2002, 103, 1, p. 48–52.

32. Mannaerts, BM, Geurts, TB, Odink, J. A randomized three-way cross-over study in healthy pituitary-suppressed women to compare the bioavailability of human chorionic gonadotrophin (Pregnyl) after intramuscular and subcutaneous administration. Human Reproduction 1998; 13(6):1461–4.

33. Minas, V., Loutradis, D., Makrigiannakis, A. Factors controlling blastocyst implantation. Reprod Biomed Online, 2005, 10, 2, p. 205–216.

34. Mochtar, MH., Van der Veen, F., Ziech, M., et al. Recombinant luteinizing hormone (rLH) for controlled ovarian hyperstimulation in assisted reproductive cycles. Cochrane Database of Systematic Reviews 2007, Issue 2. [DOI: 10.1002/14651858.CD005070.pub2.]

35. Nosarka, S., Kruger, T., Siebert, I., Grové, D. Luteal phase support in in vitro fertilization: meta-analysis of randomized trials. Gynecol Obstet Invest, 2005, 60, 2, p. 67–74.

36. Nyboe Andersen, A., Popovic-Todorovic, B., Schmidt, KT., et al. Progesterone supplementation during early gestations after IVF or ICSI has no effect on the delivery rates: a randomized controlled trial. Hum Reprod, 2002, 17, 2, p. 357–361.

37. Penzias, AS. Luteal phase support. Fertil Steril, 2002, 77, 2, p. 318–323.

38. Pirard, C., Donnez, J., Loumaye, E. GnRH agonist as novel luteal support: results of a randomized, parallel group, feasibility study using intranasal administration of buserelin. Hum Reprod 2005, 20(7), p. 1798–1804.

39. Pritts, EA., Atwood, AK. Luteal phase support in infertility treatment: a meta-analysis of the randomized trials. Hum Reprod, 2002, 17, 9, p. 2287–2299.

40. Proctor, A., Hurst, BS., Marshburn, PB., et al. Effect of progesterone supplementation in early pregnancy on the pregnancy outcome after in vitro fertilization. Fertil Steril, 2006, 85, 5, p. 1550–1552.

41. Propst, AM., Hill, JA., Ginsburg, ES., et al. A randomized study comparing Crinone 8% and intramuscular progesterone supplementation in in vitro fertilization-embryo transfer cycles. Fertil Steril, 2001, 76, 6, p. 1144–1149.

42. Saal, W., Glowania, HJ., Hengst, W., Happ, J. Pharmacodynamics and pharmacokinetics after subcutaneous and intramuscular injection of human chorionic gonadotropin. Fertil Steril, 1991, 56(2), p. 225–229.

43. Scott, R., Navot, D., Liu HC., Rosenwaks, Z. A human in vivo model for the luteoplacental shift. Fertil Steril, 1991, 56, 3, p. 481–484.

44. Simunic, V., Tomic, V., Tomic, J., Nizic D. Comparative study of the efficacy and tolerability of two vaginal progesterone formulations, Crinone 8% gel and Utrogestan capsules, used for luteal support. Fertil Steril, 2007, 87, 1, p. 83–87.

45. Smitz, J., Devroey, P., Camus, M., et al. The luteal phase and early pregnancy after combined GnRH-agonist/HMG treatment for superovulation in IVF or GIFT. Hum Reprod, 1988, 3, 5, p. 585–590.

46. Tesarik, J., Hazout, A., Mendoza, C. Enhancement of embryo developmental potential by a single administration of GnRH agonist at the time of implantation. Human Reprod, 2004, 19(5), p. 1176–1180.

47. Toner, JP. The luteal phase: luteal support protocols. In Gardner, DK., Weissman, A., Howles, CM. et al. (eds.) Textbook of assisted reproductive techniques. 2nd ed. London: Tailor & Francis, 2004, p. 639–650.

48. Vande Wiele, RL., Bogumil, J., Dyrenfurth, I., et al. Mechanisms regulating the menstrual cycle in women. Recent Prog Horm Res, 1970, 26, p. 63–103.

49. Whelan, JG. 3rd, Vlahos, NF. The ovarian hyperstimulation syndrome. Fertil Steril, 2000, 73, 5, p. 883–896.

50. Wikland, M., Borg, J., Forsberg, AS., et al. Human chorionic-gonadotropin self-administered by the subcutaneous route to induce oocyte maturation in an in-vitro fertilization and embryo- transfer program. Human Reprod, 1995, 10(7), p. 1667–1670.

51. van der Linden, M., Buckingham, K., Farquhar, C., et al. Luteal phase support for assisted reproduction cycles. Cochrane Database of Systematic Reviews 2011, Issue 10. Art. No.: CD009154. doi: 10.1002/ 14651858.CD009154.pub2.

52. www.uzis.cz. (data zde uvedená se vztahují ke stavu registru ze dne 29. června 2015, www.uzis.cz )

53. www eshre (mezinárodní data vychází z evropského registru asistované reprodukce - EIM, fungujícího pod správou Evropské společnosti lidské reprodukce a embryologie -ESHRE) ESHRE, 2014 b. ART fact sheet. ESHRE. European Society of Human Reproduction and Embryology [online]. 2014 [cit. 2015-07-01]. Dostupné z: http://www.eshre.eu/Guidelines-and-Legal/ART-fact-sheet.aspx

Labels
Paediatric gynaecology Gynaecology and obstetrics Reproduction medicine

Article was published in

Czech Gynaecology

Issue 1

2017 Issue 1

Most read in this issue
Login
Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account

#ADS_BOTTOM_SCRIPTS#