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CTRI Number  CTRI/2024/07/070749 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 28/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical pregnancy rates of frozen embryo transfer with and without use of growth hormone in recipients of oocyte donation . 
Scientific Title of Study   Clinical pregnancy rates of frozen embryo transfer with and without use of growth hormone in recipients of oocyte donation . 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr prasanta Kumar Nayak 
Designation  Clinical head 
Affiliation  OASIS fertility hospital-U unit of Sadguru healthcare services pvt.Ltd, Bhubaneswar 
Address  Oasis Fertility Hospital, HIG-1, Gangadhar Meher Marg, Above trends footwear, Jayadev Vihar, Bhubaneswar

Khordha
ORISSA
751023
India 
Phone  9131330412  
Fax    
Email  drpknayak2020@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr prasanta Kumar Nayak 
Designation  Clinical head 
Affiliation  OASIS fertility hospital-U unit of Sadguru healthcare services pvt.Ltd, Bhubaneswar 
Address  Oasis Fertility Hospital, HIG-1, Gangadhar Meher Marg, Above trends footwear, Jayadev Vihar, Bhubaneswar

Khordha
ORISSA
751023
India 
Phone  9131330412  
Fax    
Email  drpknayak2020@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr prasanta Kumar Nayak 
Designation  Clinical head 
Affiliation  OASIS fertility hospital-U unit of Sadguru healthcare services pvt.Ltd, Bhubaneswar 
Address  Oasis Fertility Hospital, HIG-1, Gangadhar Meher Marg, Above trends footwear, Jayadev Vihar, Bhubaneswar

Khordha
ORISSA
751023
India 
Phone  9131330412  
Fax    
Email  drpknayak2020@gmail.com  
 
Source of Monetary or Material Support  
OASIS FERTILITY HOSPITAL, HIG 1 , Gangadhar Meher Marg, Above Trends Foot wear, Jayadev Vihar, Bhubaneswar,Odisha, India-751023 
 
Primary Sponsor  
Name  OASIS FERTILITY HOSPITAL 
Address  Oasis Fertility Hospital, HIG 1, Above trends footwear, Gangadhar Meher Marg, Bhubaneswar,India, Odisha-751023 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
Nil  Not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasanta Kumar Nayak  OASIS Fertility Hospital  Building no.HIG 1,2nd floor,room no-5, Gangadhar Meher Marg, Jayadev Vihar, Bhubaneswar
Khordha
ORISSA 		 9131330412

drpknayak2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OASIS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O090||Supervision of pregnancy with history of infertility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Recombinant growth hormone  We have planned to conduct a multicentric RCT at OASIS fertility hospital at Bhubaneswar over a period of 1.5 years. Those patients planned for FET HRT cycles will be randomized after taking their consents. Consents from the donors will also be taken for this purpose. We will administer 4 units of growth hormone from Day-2 of HRT till Day-12(total 10 doses) , in FET cycles of recipients of oocyte donation and will compare the clinical pregnancy outcomes with those of FET cycles of recipients of donor oocytes without using growth hormone. These patients will be followed till clinical pregnancy is detected.  
Comparator Agent  Without using Recombinant growth hormone  In this arm Growth hormone is not used during endometrial preparation for embryo transfer 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  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
 
 
ExclusionCriteria 
Details  a) Congenital or acquired uterine malformations
b) Endometrial polyps and submucosal fibroids
c) Intrauterine adhesion
d) Patients for FET cycles with self oocytes
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To find out the clinical pregnancy rates of frozen embryo transfer (FET)
with the use of recombinant human growth hormone (rhGH) in oocyte donation programme.
 		 one and half years 
 
Secondary Outcome  
Outcome  TimePoints 
Ongoing pregnancy rates  Three to 4 months from the time of recruitment 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 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.

 


 
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