跳至主要内容
临床试验/CTRI/2024/07/070749
CTRI/2024/07/070749招募中不适用

Clinical pregnancy rates of frozen embryo transfer with and without use of growth hormone in recipients of oocyte donation .

OASIS FERTILITY HOSPITAL1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年7月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
46
试验地点
1
主要终点
To find out the clinical pregnancy rates of frozen embryo transfer (FET)

研究概览

简要总结

Recently some studies have shown that administration of Growth Hormone (GH) have improved the uterine receptivity of embryo [1]. Some other published studies have shown that simultaneous administration of GH with hormone-replacement therapy could improve clinical outcomes after frozen embryo transfer by increasing endometrial blood perfusion and expression of cytokines related to endometrial receptivity [2]. There are many studies which have already shown that, administration of growth hormone (GH) during ovarian stimulation in women with poor ovarian response improve success rates of IVF [3–8]. This improvement is related to the beneficial effects of GH on oocyte quality leading to a higher number of oocytes retrieval, higher fertilization rate, higher number of embryos, higher pregnancy rate and higher live birth also[5-13]. Growth hormone (GH) is a peptide hormone which has important roles in cell growth and metabolism in the body [14-16]. Since the uterus is a site of both GH production and GH action, the beneficial effect of GH on assisted reproduction can also be due to an action of GH on the uterus, enhancing the receptivity of endometrium leading to improved embryo implantation [17]. Research outcomes have shown that use of GH in super ovulated cows increase embryonic development, and also improve post transfer pregnancy rates when given to embryo recipients [18]. Hence further studies of GH effects on human uterine receptivity are definitely warranted before any clinical recommendation.

  1. Altmäe S, Mendoza-Tesarik R, Mendoza C, Mendoza N, Cucinelli F, Tesarik J. Effect of Growth Hormone on Uterine Receptivity in Women With Repeated Implantation Failure in an Oocyte Donation Program: A Randomized Controlled Trial. J Endocr Soc. 2017 Dec 19;2(1):96-105. doi: 10.1210/js.2017-00359. Erratum in: J Endocr Soc. 2018 Jan 08;2(2):133. PMID: 29379897; PMCID: PMC5779111.

  2. Xue-Mei W, Hong J, Wen-Xiang Z, Yang L. The effects of growth hormone on clinical outcomes after frozen-thawed embryo transfer. Int J Gynaecol Obstet. 2016;133(3):347–350

  3. Tesarik J, Hazout A, Mendoza C. Improvement of delivery and live birth rates after ICSI in women aged .40 years by ovarian co-stimulation with growth hormone. Hum Reprod. 2005;20(9):2536–2541.

  4. Du XF, Yang XH, Li J, Hao M, Guo YH. Growth hormone co-treatment within a GnRH agonist long protocol improves implantation and pregnancy rates in patients undergoing IVF-ET. Arch Gynecol Obstet. 2016;294(4):877–883.

  5. Kolibianakis EM, Venetis CA, Diedrich K, Tarlatzis BC, Griesinger G. Addition of growth hormone to gonadotrophins in ovarian stimulation of poor responders treated by in-vitro fertilization: a systematic review and meta-analysis. Hum Reprod Update. 2009;15(6):613–622.

  6. Duffy JM, Ahmad G, Mohiyiddeen L, Nardo LG, Watson A. Growth hormone for in vitro fertilization. Cochrane Database Syst Rev. 2010;(1):CD000099.

  7. Li X-L, Wang L, Lv F, Huang X-M, Wang L-P, Pan Y, Zhang X-M. The influence of different growth hormone addition protocols to poor ovarian responders on clinical outcomes in controlled ovary stimulation cycles: a systematic review and meta-analysis. Medicine (Baltimore). 2017;96(12):e6443. doi: 10.1210/js.2017-00359 | Journal of the Endocrine Society | 103

  8. Bassiouny YA, Dakhly DMR, Bayoumi YA, Hashish NM. Does the addition of growth hormone to the in vitro fertilization/intracytoplasmic sperm injection antagonist protocol improve outcomes in poor responders? A randomized, controlled trial. Fertil Steril. 2016;105(3):697–702.

  9. Kucuk T, Kozinoglu H, Kaba A. Growth hormone co-treatment within a GnRH agonist long protocol in patients with poor ovarian response: a prospective, randomized, clinical trial. J Assist Reprod Genet. 2008;25(4):123–127.

  10. Bassiouny YA, Dakhly DMR, Bayoumi YA, Hashish NM. Does the addition of growth hormone to the in vitro fertilization/intracytoplasmic sperm injection antagonist protocol improve outcomes in poor responders? A randomized, controlled trial. Fertil Steril. 2016;105(3):697–702.

  11. Hazout A, Junca A, M ´en ´ezo Y, Demouzon J, Cohen-Bacrie P. Effect of growth hormone on oocyte competence in patients with multiple IVF failures. Reprod Biomed Online. 2009;18(5):664–670.

  12. Lattes K, Brassesco M, Gomez M, Checa MA. Low-dose growth hormone supplementation increases clinical pregnancy rate in poor responders undergoing in vitro fertilisation. Gynecol Endocrinol. 2015; 31(7):565–568.

  13. Yovich JL, Stanger JD. Growth hormone supplementation improves implantation and pregnancy productivity rates for poor-prognosis patients undertaking IVF. Reprod Biomed Online. 2010;21(1): 37–49.

  14. M ´en ´ezo YJR, el Mouatassim S, Chavrier M, Servy EJ, Nicolet B. Human oocytes and preimplantation embryos express mRNA for growth hormone receptor. Zygote. 2003;11(4):293–297.

  15. Abir R, Garor R, Felz C, Nitke S, Krissi H, Fisch B. Growth hormone and its receptor in human ovaries from fetuses and adults. Fertil Steril. 2008;90(4, Suppl):1333–1339.

  16. Menezo YJR, Nicollet B, Rollet J, Hazout A. Pregnancy and delivery after in vitro maturation of naked ICSI-GV oocytes with GH and transfer of a frozen thawed blastocyst: case report. J Assist Reprod Genet. 2006;23(1):47–49.

  17. Hull KL, Harvey S. Growth hormone and reproduction: a review of endocrine and autocrine/paracrine interactions. Int J Endocrinol. 2014;2014:234014.

  18. Moreira F, Badinga L, Burnley C, Thatcher WW. Bovine somatotropin increases embryonic development in superovulated cows and improves post-transfer pregnancy rates when given to lactating recipient cows. Theriogenology. 2002;57(4):1371–1387.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
30.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • a) Patients for FET HRT cycles with donor oocytes willing to take GH b) Embryos frozen by vitrification within the previous 2 years c) At least two embryos frozen per patient.
  • d) Age above 30 years.

排除标准

  • a) Congenital or acquired uterine malformations b) Endometrial polyps and submucosal fibroids c) Intrauterine adhesion d) Patients for FET cycles with self oocytes.

结局指标

主要结局

To find out the clinical pregnancy rates of frozen embryo transfer (FET)

时间窗: one and half years

with the use of recombinant human growth hormone (rhGH) in oocyte donation programme.

时间窗: one and half years

次要结局

  • Ongoing pregnancy rates(Three to 4 months from the time of recruitment)

研究者

发起方
OASIS FERTILITY HOSPITAL
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr prasanta Kumar Nayak

OASIS fertility hospital-U unit of Sadguru healthcare services pvt.Ltd, Bhubaneswar

研究点 (1)

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