drugset / Trial / NCT01581359
The Effect of Pre-treatment With GnRH Analogues Prior in Vitro Fertilization in Patients With Endometriosis
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether the administration of an analogue of gonadotropin-releasing hormone (GnRH) during the three months prior to the performing of an IVF may improve the response to ovarian stimulation, implantation rate and clinical pregnancy rate in patients with endometriosis/ endometriomas.
Timeline
- Start
- 2012-03
- Primary completion
- 2015-03
- Completion
- 2015-05
Publications
- Background Matson PL, Yovich JL. The treatment of infertility associated with endometriosis by in vitro fertilization. Fertil Steril. 1986 Sep;46(3):432-4. doi: 10.1016/s0015-0282(16)49581-6.
- Background Simon C, Gutierrez A, Vidal A, de los Santos MJ, Tarin JJ, Remohi J, Pellicer A. Outcome of patients with endometriosis in assisted reproduction: results from in-vitro fertilization and oocyte donation. Hum Reprod. 1994 Apr;9(4):725-9. doi: 10.1093/oxfordjournals.humrep.a138578.
- Background Arici A, Oral E, Bukulmez O, Duleba A, Olive DL, Jones EE. The effect of endometriosis on implantation: results from the Yale University in vitro fertilization and embryo transfer program. Fertil Steril. 1996 Mar;65(3):603-7. doi: 10.1016/s0015-0282(16)58162-x.
- Background Cahill DJ, Wardle PG, Maile LA, Harlow CR, Hull MG. Ovarian dysfunction in endometriosis-associated and unexplained infertility. J Assist Reprod Genet. 1997 Nov;14(10):554-7. doi: 10.1023/a:1022568331845.
- Background Inoue M, Kobayashi Y, Honda I, Awaji H, Fujii A. The impact of endometriosis on the reproductive outcome of infertile patients. Am J Obstet Gynecol. 1992 Jul;167(1):278-82. doi: 10.1016/s0002-9378(11)91675-5.
- Background Dmowski WP, Rana N, Michalowska J, Friberg J, Papierniak C, el-Roeiy A. The effect of endometriosis, its stage and activity, and of autoantibodies on in vitro fertilization and embryo transfer success rates. Fertil Steril. 1995 Mar;63(3):555-62. doi: 10.1016/s0015-0282(16)57425-1.
- Background Olivennes F, Feldberg D, Liu HC, Cohen J, Moy F, Rosenwaks Z. Endometriosis: a stage by stage analysis--the role of in vitro fertilization. Fertil Steril. 1995 Aug;64(2):392-8. doi: 10.1016/s0015-0282(16)57740-1.
- Background Tanbo T, Omland A, Dale PO, Abyholm T. In vitro fertilization/embryo transfer in unexplained infertility and minimal peritoneal endometriosis. Acta Obstet Gynecol Scand. 1995 Aug;74(7):539-43. doi: 10.3109/00016349509024386.
- Background Huang HY, Lee CL, Lai YM, Chang MY, Chang SY, Soong YK. The outcome of in vitro fertilization and embryo transfer therapy in women with endometriosis failing to conceive after laparoscopic conservative surgery. J Am Assoc Gynecol Laparosc. 1997 May;4(3):299-303. doi: 10.1016/s1074-3804(05)80219-1.
- Background Hickman TN. Impact of endometriosis on implantation. Data from the Wilford Hall Medical Center IVF-ET Program. J Reprod Med. 2002 Oct;47(10):801-8.
- Background Barnhart K, Dunsmoor-Su R, Coutifaris C. Effect of endometriosis on in vitro fertilization. Fertil Steril. 2002 Jun;77(6):1148-55. doi: 10.1016/s0015-0282(02)03112-6.
- Background Wardle PG, Mitchell JD, McLaughlin EA, Ray BD, McDermott A, Hull MG. Endometriosis and ovulatory disorder: reduced fertilisation in vitro compared with tubal and unexplained infertility. Lancet. 1985 Aug 3;2(8449):236-9. doi: 10.1016/s0140-6736(85)90289-2.
- Background Hull MG, Williams JA, Ray B, McLaughlin EA, Akande VA, Ford WC. The contribution of subtle oocyte or sperm dysfunction affecting fertilization in endometriosis-associated or unexplained infertility: a controlled comparison with tubal infertility and use of donor spermatozoa. Hum Reprod. 1998 Jul;13(7):1825-30. doi: 10.1093/humrep/13.7.1825.
- Background Bergendal A, Naffah S, Nagy C, Bergqvist A, Sjoblom P, Hillensjo T. Outcome of IVF in patients with endometriosis in comparison with tubal-factor infertility. J Assist Reprod Genet. 1998 Oct;15(9):530-4. doi: 10.1023/a:1022526002421.
- Background Pal L, Shifren JL, Isaacson KB, Chang Y, Leykin L, Toth TL. Impact of varying stages of endometriosis on the outcome of in vitro fertilization-embryo transfer. J Assist Reprod Genet. 1998 Jan;15(1):27-31. doi: 10.1023/a:1022574221115.
- Background Norenstedt SN, Linderoth-Nagy C, Bergendal A, Sjoblom P, Bergqvist A. Reduced developmental potential in oocytes from women with endometriosis. J Assist Reprod Genet. 2001 Dec;18(12):644-9. doi: 10.1023/a:1013111200251.
- Background O'Shea RT, Chen C, Weiss T, Jones WR. Endometriosis and in-vitro fertilisation. Lancet. 1985 Sep 28;2(8457):723. doi: 10.1016/s0140-6736(85)92957-5. No abstract available.
- Background Yovich JL, Yovich JM, Tuvik AI, Matson PL, Willcox DL. In-vitro fertilisation for endometriosis. Lancet. 1985 Sep 7;2(8454):552. doi: 10.1016/s0140-6736(85)90485-4. No abstract available.
- Background Garrido N, Navarro J, Remohi J, Simon C, Pellicer A. Follicular hormonal environment and embryo quality in women with endometriosis. Hum Reprod Update. 2000 Jan-Feb;6(1):67-74. doi: 10.1093/humupd/6.1.67.
- Background Pellicer A, Valbuena D, Bauset C, Albert C, Bonilla-Musoles F, Remohi J, Simon C. The follicular endocrine environment in stimulated cycles of women with endometriosis: steroid levels and embryo quality. Fertil Steril. 1998 Jun;69(6):1135-41. doi: 10.1016/s0015-0282(98)00085-5.
- Background Pellicer A, Albert C, Mercader A, Bonilla-Musoles F, Remohi J, Simon C. The follicular and endocrine environment in women with endometriosis: local and systemic cytokine production. Fertil Steril. 1998 Sep;70(3):425-31. doi: 10.1016/s0015-0282(98)00204-0.
- Background Smith MP, Keay SD, Margo FC, Harlow CR, Wood PJ, Cahill DJ, Hull MG. Total cortisol levels are reduced in the periovulatory follicle of infertile women with minimal-mild endometriosis. Am J Reprod Immunol. 2002 Jan;47(1):52-6. doi: 10.1034/j.1600-0897.2002.1o122.x.
- Background Cunha-Filho JS, Lemos NA, Freitas FM, Kiefer K, Faller M, Passos EP. Insulin-like growth factor (IGF)-1 and IGF binding protein-1 and -3 in the follicular fluid of infertile patients with endometriosis. Hum Reprod. 2003 Feb;18(2):423-8. doi: 10.1093/humrep/deg077.
- Background Carlberg M, Nejaty J, Froysa B, Guan Y, Soder O, Bergqvist A. Elevated expression of tumour necrosis factor alpha in cultured granulosa cells from women with endometriosis. Hum Reprod. 2000 Jun;15(6):1250-5. doi: 10.1093/humrep/15.6.1250.
- Background Nakahara K, Saito H, Saito T, Ito M, Ohta N, Takahashi T, Hiroi M. Ovarian fecundity in patients with endometriosis can be estimated by the incidence of apoptotic bodies. Fertil Steril. 1998 May;69(5):931-5. doi: 10.1016/s0015-0282(98)00038-7.
- Background Toya M, Saito H, Ohta N, Saito T, Kaneko T, Hiroi M. Moderate and severe endometriosis is associated with alterations in the cell cycle of granulosa cells in patients undergoing in vitro fertilization and embryo transfer. Fertil Steril. 2000 Feb;73(2):344-50. doi: 10.1016/s0015-0282(99)00507-5.
- Background Sung L, Mukherjee T, Takeshige T, Bustillo M, Copperman AB. Endometriosis is not detrimental to embryo implantation in oocyte recipients. J Assist Reprod Genet. 1997 Mar;14(3):152-6. doi: 10.1007/BF02766132.
- Background Pellicer A, Oliveira N, Ruiz A, Remohi J, Simon C. Exploring the mechanism(s) of endometriosis-related infertility: an analysis of embryo development and implantation in assisted reproduction. Hum Reprod. 1995 Dec;10 Suppl 2:91-7. doi: 10.1093/humrep/10.suppl_2.91.
- Background Ho HY, Lee RK, Hwu YM, Lin MH, Su JT, Tsai YC. Poor response of ovaries with endometrioma previously treated with cystectomy to controlled ovarian hyperstimulation. J Assist Reprod Genet. 2002 Nov;19(11):507-11. doi: 10.1023/a:1020970417778.
- Background Aboulghar MA, Mansour RT, Serour GI, Al-Inany HG, Aboulghar MM. The outcome of in vitro fertilization in advanced endometriosis with previous surgery: a case-controlled study. Am J Obstet Gynecol. 2003 Feb;188(2):371-5. doi: 10.1067/mob.2003.13.
- Background Canis M, Pouly JL, Tamburro S, Mage G, Wattiez A, Bruhat MA. Ovarian response during IVF-embryo transfer cycles after laparoscopic ovarian cystectomy for endometriotic cysts of >3 cm in diameter. Hum Reprod. 2001 Dec;16(12):2583-6. doi: 10.1093/humrep/16.12.2583.
- Background Marconi G, Vilela M, Quintana R, Sueldo C. Laparoscopic ovarian cystectomy of endometriomas does not affect the ovarian response to gonadotropin stimulation. Fertil Steril. 2002 Oct;78(4):876-8. doi: 10.1016/s0015-0282(02)03326-5.
- Background Donnez J, Wyns C, Nisolle M. Does ovarian surgery for endometriomas impair the ovarian response to gonadotropin? Fertil Steril. 2001 Oct;76(4):662-5. doi: 10.1016/s0015-0282(01)02011-8.
- Background Wyns C, Donnez J. [Laser vaporization of ovarian endometriomas: the impact on the response to gonadotrophin stimulation]. Gynecol Obstet Fertil. 2003 Apr;31(4):337-42. doi: 10.1016/s1297-9589(03)00069-9. French.
- Background Garcia-Velasco JA, Mahutte NG, Corona J, Zuniga V, Giles J, Arici A, Pellicer A. Removal of endometriomas before in vitro fertilization does not improve fertility outcomes: a matched, case-control study. Fertil Steril. 2004 May;81(5):1194-7. doi: 10.1016/j.fertnstert.2003.04.006.
- Background Dicker D, Goldman JA, Feldberg D, Ashkenazi J, Levy T. Transvaginal ultrasonic needle-guided aspiration of endometriotic cysts before ovulation induction for in vitro fertilization. J In Vitro Fert Embryo Transf. 1991 Oct;8(5):286-9. doi: 10.1007/BF01139786.
- Background Suganuma N, Wakahara Y, Ishida D, Asano M, Kitagawa T, Katsumata Y, Moriwaki T, Furuhashi M. Pretreatment for ovarian endometrial cyst before in vitro fertilization. Gynecol Obstet Invest. 2002;54 Suppl 1:36-40; discussion 41-2. doi: 10.1159/000066293.
- Background Dicker D, Ashkenazi J, Feldberg D, Levy T, Dekel A, Ben-Rafael Z. Severe abdominal complications after transvaginal ultrasonographically guided retrieval of oocytes for in vitro fertilization and embryo transfer. Fertil Steril. 1993 Jun;59(6):1313-5. doi: 10.1016/s0015-0282(16)55997-4.
- Background Yaron Y, Peyser MR, Samuel D, Amit A, Lessing JB. Infected endometriotic cysts secondary to oocyte aspiration for in-vitro fertilization. Hum Reprod. 1994 Sep;9(9):1759-60. doi: 10.1093/oxfordjournals.humrep.a138789.
- Background Nargund G, Parsons J. Infected endometriotic cysts secondary to oocyte aspiration for in-vitro fertilization. Hum Reprod. 1995 Jun;10(6):1555. doi: 10.1093/humrep/10.6.1555-a. No abstract available.
- Background Younis JS, Ezra Y, Laufer N, Ohel G. Late manifestation of pelvic abscess following oocyte retrieval, for in vitro fertilization, in patients with severe endometriosis and ovarian endometriomata. J Assist Reprod Genet. 1997 Jul;14(6):343-6. doi: 10.1007/BF02765839.
- Background Wei CF, Chen SC. Pelvic abscess after ultrasound-guided aspiration of endometrioma: a case report. Zhonghua Yi Xue Za Zhi (Taipei). 1998 Oct;61(10):603-7.
- Background Kim CH, Chae HD, Kang BM, Chang YS, Mok JE. The immunotherapy during in vitro fertilization and embryo transfer cycles in infertile patients with endometriosis. J Obstet Gynaecol Res. 1997 Oct;23(5):463-70. doi: 10.1111/j.1447-0756.1997.tb00874.x.
- Background Tei C, Miyazaki T, Kuji N, Tanaka M, Sueoka K, Yoshimura Y. Effect of danazol on the pregnancy rate in patients with unsuccessful in vitro fertilization-embryo transfer. J Reprod Med. 1998 Jun;43(6):541-6.
- Background Oehninger S, Brzyski RG, Muasher SJ, Acosta AA, Jones GS. In-vitro fertilization and embryo transfer in patients with endometriosis: impact of a gonadotrophin releasing hormone agonist. Hum Reprod. 1989 Jul;4(5):541-4. doi: 10.1093/oxfordjournals.humrep.a136941.
- Background Dicker D, Goldman GA, Ashkenazi J, Feldberg D, Voliovitz I, Goldman JA. The value of pre-treatment with gonadotrophin releasing hormone (GnRH) analogue in IVF-ET therapy of severe endometriosis. Hum Reprod. 1990 May;5(4):418-20. doi: 10.1093/oxfordjournals.humrep.a137114.
- Background Dale PO, Tanbo T, Abyholm T. Endometriosis-associated infertility treated by long-term gonadotropin-releasing hormone agonist administration and assisted fertilization. J In Vitro Fert Embryo Transf. 1990 Jun;7(3):180-1. doi: 10.1007/BF01135686.
- Background Nakamura K, Oosawa M, Kondou I, Inagaki S, Shibata H, Narita O, Suganuma N, Tomoda Y. Menotropin stimulation after prolonged gonadotropin releasing hormone agonist pretreatment for in vitro fertilization in patients with endometriosis. J Assist Reprod Genet. 1992 Apr;9(2):113-7. doi: 10.1007/BF01203749.
- Background Curtis P, Jackson A, Bernard A, Shaw RW. Pretreatment with gonadotrophin releasing hormone (GnRH) analogue prior to in vitro fertilisation for patients with endometriosis. Eur J Obstet Gynecol Reprod Biol. 1993 Dec 30;52(3):211-6. doi: 10.1016/0028-2243(93)90074-m.
- Background Marcus SF, Edwards RG. High rates of pregnancy after long-term down-regulation of women with severe endometriosis. Am J Obstet Gynecol. 1994 Sep;171(3):812-7. doi: 10.1016/0002-9378(94)90103-1.
- Background Chedid S, Camus M, Smitz J, Van Steirteghem AC, Devroey P. Comparison among different ovarian stimulation regimens for assisted procreation procedures in patients with endometriosis. Hum Reprod. 1995 Sep;10(9):2406-11. doi: 10.1093/oxfordjournals.humrep.a136308.
- Background Ruiz-Velasco V, Allende S. Goserelin followed by assisted reproduction: results in infertile women with endometriosis. Int J Fertil Womens Med. 1998 Jan-Feb;43(1):18-23.
- Background Sallam HN, Garcia-Velasco JA, Dias S, Arici A. Long-term pituitary down-regulation before in vitro fertilization (IVF) for women with endometriosis. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004635. doi: 10.1002/14651858.CD004635.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Triptorelin | Other / unclassified | 3.75 mg | Subcutaneous |