Subcutaneous progesterone versus vaginal progesterone gel for luteal phase support in in vitro fertilization: A noninferiority randomized controlled study

Fertility and Sterility

Volumn 101, Issue 1, 2014, Pages

  Lockwood, Gillian ^a   Griesinger, Georg ^b   Cometti, Barbara ^c  

^a Midland Fertility Services   (United Kingdom)

^b UNIVERSITY OF LÜBECK   (Germany)

^c Institut Biochimique   (Switzerland)

Author keywords

in vitro fertilization; intracytoplasmic sperm injection; Luteal phase support; pregnancy; progesterone

Indexed keywords

CHORIONIC GONADOTROPIN; FOLLITROPIN; GONADORELIN AGONIST; GONADORELIN ANTAGONIST; HUMAN MENOPAUSAL GONADOTROPIN; ORAL CONTRACEPTIVE AGENT; PROGESTERONE; PROLUTEX; RECOMBINANT CHORIONIC GONADOTROPIN; RECOMBINANT FOLLITROPIN; UNCLASSIFIED DRUG;

ABDOMINAL DISCOMFORT; ABDOMINAL DISTENSION; ABDOMINAL PAIN; ABDOMINAL TENDERNESS; ABORTION; ACNE; ADULT; APPLICATION SITE DISCOMFORT; APPLICATION SITE IRRITATION; APPLICATION SITE PAIN; APPLICATION SITE PRURITUS; APPLICATION SITE SWELLING; ARTICLE; BACTERIAL INFECTION; BIRTH DEFECT; BLADDER DISCOMFORT; BREAST DISCOMFORT; BREAST DISEASE; BREAST HYPERTROPHY; BREAST SWELLING; BREAST TENDERNESS; BURNING SENSATION; CLINICAL PROTOCOL; CONSTIPATION; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DERMATITIS; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRY SKIN; ECTOPIC PREGNANCY; EMBRYO TRANSFER; ERYTHEMA; FACE EDEMA; FEMALE; FEMALE INFERTILITY; FERTILIZATION IN VITRO; FLATULENCE; GASTROENTERITIS; GASTROINTESTINAL DISEASE; GASTROINTESTINAL PAIN; GEL; GENITAL TRACT INFECTION; HEADACHE; HERPES VIRUS INFECTION; HUMAN; IMPLANTATION; INFERTILITY; INJECTION SITE BLEEDING; INJECTION SITE INDURATION; INTRACYTOPLASMIC SPERM INJECTION; LIVE BIRTH; LOWER ABDOMINAL PAIN; LUTEAL PHASE; MAJOR CLINICAL STUDY; MALE INFERTILITY; MASTALGIA; MULTICENTER STUDY; MYCOSIS; NAUSEA; NEUROLOGIC DISEASE; NIGHT SWEAT; NIPPLE SWELLING; OOCYTE RETRIEVAL; OPEN STUDY; OUTCOME ASSESSMENT; OVARY CYST; OVARY HYPERSTIMULATION; OVARY TORSION; PAPULAR RASH; PARALLEL DESIGN; PATIENT SATISFACTION; PELVIC PAIN; PIGMENT DISORDER; PLEURA EFFUSION; POLLAKISURIA; PREGNANCY RATE; PREMENSTRUAL SYNDROME; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RASH; REPRODUCTIVE TOXICITY; RETCHING; SKIN ALLERGY; SKIN DISCOLORATION; SKIN DISEASE; SKIN PRURITUS; SOMNOLENCE; SPONTANEOUS ABORTION; SPOTTING; SWELLING; UPPER ABDOMINAL PAIN; URINARY TRACT INFECTION; URINARY TRACT PAIN; UTERINE SPASM; VAGINA BLEEDING; VAGINA DISCHARGE; VAGINA PAIN; VAGINAL DRYNESS; VAGINITIS; VOMITING; VULVA PRURITUS; VULVOVAGINAL BURNING SENSATION; VULVOVAGINAL DISCOMFORT; VULVOVAGINITIS; XEROSTOMIA;

EID: 84891555726     PISSN: 00150282     EISSN: 15565653     Source Type: Journal    
DOI: 10.1016/j.fertnstert.2013.09.010     Document Type: Article

References (35)

1. M. van der Linden, K. Buckingham, C. Farquhar, J.A. Kremer, and M. Metwally Luteal phase support for assisted reproduction cycles Cochrane 5 2011 CD009154
2. A. Tavaniotou, C. Albano, J. Smitz, and P. Devroey Impact of ovarian stimulation on corpus luteum function and embryonic implantation J Reprod Immunol 55 2002 123 130 (Pubitemid 34626157)
3. A. Tavaniotou, J. Smitz, C. Bourgain, and P. Devroey Comparison between different routes of progesterone administration as luteal phase support in infertility treatments Hum Reprod Update 6 2000 139 148 (Pubitemid 30182295)
4. H. Levine 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 74 2000 836 837
5. J.H. Check Luteal Phase Support in assisted reproductive technology treatment: focus on Endometrin(R) (progesterone) vaginal insert Ther Clin Risk Manag 5 2009 403 407
6. A.M. Propst, J.A. Hill, E.S. Ginsburg, S. Hurwitz, J. Politch, and E.H. Yanushpolsky A randomized study comparing Crinone 8% and intramuscular progesterone supplementation in in vitro fertilization-embryo transfer cycles Fertil Steril 76 2001 1144 1149 (Pubitemid 33116378)
7. L. Costabile, S. Gerli, C. Manna, D. Rossetti, G.C. Di Renzo, and V. Unfer A prospective randomized study comparing intramuscular progesterone and 17alpha-hydroxyprogesterone caproate in patients undergoing in vitro fertilization-embryo transfer cycles Fertil Steril 76 2001 394 396 (Pubitemid 32703836)
8. A. Lightman, S. Kol, and J. Itskovitz-Eldor A prospective randomized study comparing intramuscular with intravaginal natural progesterone in programmed thaw cycles Hum Reprod 14 1999 2596 2599 (Pubitemid 29473935)
9. K.M. Silverberg, T.C. Vaughn, L.J. Hansard, N.Z. Burger, and T. Minter Vaginal (Crinone 8%) gel vs. intramuscular progesterone in oil for luteal phase support in in vitro fertilization: a large prospective trial Fertil Steril 97 2012 344 348
10. C. Posaci, J. Smitz, M. Camus, K. Osmanagaoglu, and P. Devroey Progesterone for the luteal support of assisted reproductive technologies: clinical options Hum Reprod 15 2000 129 148 (Pubitemid 30410135)
11. R. Fanchin, D. De Ziegler, C. Bergeron, C. Righini, C. Torrisi, and R. Frydman Transvaginal administration of progesterone Obstet Gynecol 90 1997 396 401 (Pubitemid 27357931)
12. L.M. Kimzey, J. Gumowski, G.R. Merriam, G.J. Grimes Jr., and L.M. Nelson Absorption of micronized progesterone from a nonliquefying vaginal cream Fertil Steril 56 1991 995 996
13. E. Cicinelli, V. Borraccino, D. Petruzzi, N. Mazzotta, M.L. Cerundolo, and L.M. Schonauer Pharmacokinetics and endometrial effects of the vaginal administration of micronized progesterone in an oil-based solution to postmenopausal women Fertil Steril 65 1996 860 862 (Pubitemid 26096931)
14. AHFS Progesterone 2011 AHFS Drug Information 3273 3274
15. T.R. Norman, C.A. Morse, and L. Dennerstein Comparative bioavailability of orally and vaginally administered progesterone Fertil Steril 56 1991 1034 1039
16. G. Zoppetti, N. Puppini, M. Pizzutti, A. Fini, T. Giovani, and S. Comini Water soluble progesterone-hydroxypropyl-b-cyclodextrin complex for injectable formulations J Incl Phenom Macrocycl Chem 2007 283 288
17. D. de Ziegler A randomized trial comparing the endometrial effects of daily subcutaneous administration of 25mg and 50 mg of progesterone in aqueous preparation Fertil Steril 100 2013 860 866
18. M. Sator, M. Radicioni, B. Cometti, L. Loprete, C. Leuratti, and D. Schmidl et al. Pharmacokinetics and safety profile of a novel progesterone aqueous formulation administered by the s.c. route Gynecol Endocrinol 29 2013 205 208
19. R.S. Usadi, J.M. Groll, B.A. Lessey, R.A. Lininger, R.J. Zaino, and M.A. Fritz et al. Endometrial development and function in experimentally induced luteal phase deficiency J Clin Endocrinol Metab 93 2008 4058 4064
20. R.J. Paulson Hormonal induction of endometrial receptivity Fertil Steril 96 2011 530 535
21. D. de Ziegler, M. Sator, D. Binelli, C. Leuratti, B. Cometti, and C. Bourgain et al. A randomized trial comparing the endometrial effects of daily subcutaneous administration of 25 mg and 50 mg progesterone in aqueous preparation Fertil Steril 100 2013 860 866
22. J.F.I. Strauss The synthesis and metabolism of steroids hormones Yen and Jaffe's Reproductive Endocrinology 5th Edition 2004 Martin Dunitz London 125 154
23. S. Soliman, S. Daya, J. Collins, and E.G. Hughes The role of luteal phase support in infertility treatment: a meta-analysis of randomized trials Fertil Steril 61 1994 1068 1076 (Pubitemid 24166424)
24. E.A. Pritts, and A.K. Atwood Luteal phase support in infertility treatment: a meta-analysis of the randomized trials Hum Reprod 17 2002 2287 2299 (Pubitemid 35021449)
25. S. Daya, and J. Gunby Luteal phase support in assisted reproduction cycles Cochrane Database Syst Rev 2004 CD004830
26. P.W. Zarutskie, and J.A. Phillips A meta-analysis of the route of administration of luteal phase support in assisted reproductive technology: vaginal versus intramuscular progesterone Fertil Steril 92 2009 163 169
27. E. Vaisbuch, M. Leong, and Z. Shoham Progesterone support in IVF: is evidence-based medicine translated to clinical practice? A worldwide web-based survey Reprod Biomed Online 25 2012 139 145
28. A. Nyboe Andersen, B. Popovic-Todorovic, K.T. Schmidt, A. Loft, A. Lindhard, and A. Hojgaard et al. Progesterone supplementation during early gestations after IVF or ICSI has no effect on the delivery rates: a randomized controlled trial Hum Reprod 17 2002 357 361 (Pubitemid 34168441)
29. X.R. Liu, H.Q. Mu, Q. Shi, X.Q. Xiao, and H.B. Qi The optimal duration of progesterone supplementation in pregnant women after IVF/ICSI: a meta-analysis Reprod Biol Endocrinol 10 2012 107 114
30. M.A. Aboulghar, Y.M. Amin, H.G. Al-Inany, M.M. Aboulghar, L.M. Mourad, and G.I. Serour et al. Prospective randomized study comparing luteal phase support for ICSI patients up to the first ultrasound compared with an additional three weeks Hum Reprod 23 2008 857 862
31. E. Cicinelli, D. de Ziegler, C. Bulletti, M.G. Matteo, L.M. Schonauer, and P. Galantino Direct transport of progesterone from vagina to uterus Obstet Gynecol 95 2000 403 406 (Pubitemid 30100507)
32. E. Yanushpolsky, S. Hurwitz, L. Greenberg, C. Racowsky, and M. Hornstein Crinone vaginal gel is equally effective and better tolerated than intramuscular progesterone for luteal phase support in in vitro fertilization-embryo transfer cycles: a prospective randomized study Fertil Steril 94 2010 2596 2599
33. G.G. Donders, B. Van Bulck, J. Caudron, L. Londers, A. Vereecken, and B. Spitz Relationship of bacterial vaginosis and mycoplasmas to the risk of spontaneous abortion Am J Obstet Gynecol 183 2000 431 437 (Pubitemid 30651093)
34. C.A. Flynn, A.L. Helwig, and L.N. Meurer Bacterial vaginosis in pregnancy and the risk of prematurity: a meta-analysis J Fam Pract 48 1999 885 892
35. L. Engmann, and C. Benadiva Agonist trigger: what is the best approach? Agonist trigger with aggressive luteal support Fertil Steril 97 2012 531 533