Administration of Human Chorionic Gonadotrophin Before Secretory Transformation of Frozen-thawed Embryo Transfer Cycles

hCG Clinical Trial

Official title:

Administration of Human Chorionic Gonadotrophin Before Secretory Transformation of Frozen-thawed Embryo Transfer Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340010
• Other study ID #: HCG in FET cycles
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: December 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Successful embryo implantation is complicated process that requires synchrony between good-quality embryos and receptive endometrium. Human chorionic gonadotropin (hCG), is one of the initial embryonic signals and the major embryoendometrial relationship regulator. This study will be conducted to to investigate the role of parenteral hCG used for the transfer of cryopreserved- thawed embryos with HRT cycles in the outcome of artificially prepared frozen embryo transfer (FET) cycles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 30, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• Patient age = 38 years.

• Normal 3D transvaginal ultrasound.

• At least two good quality embryos cryopreserved by vitrification.

• No GnRH agonists administration before FET cycle.

Exclusion Criteria

• Endometriosis.

• Uterine anomalies.

• Evidence of hydrosalpinx by hystrosalpingography or ultrasound.

• Evidence of immune disease, hematological or hormonal disorder.

Related Conditions & MeSH terms

• hCG

Intervention

Drug:
• Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU
From the 12th to 13th day of the cycle when endometrium reached the optimal thickness =8 mm, group 1 (hCG) will receive 10.000 IU hCG intramuscular injection in the morning then vaginal suppository progesterone 400 mg twice a day will be started in the afternoon

Locations

Country	Name	City	State
Egypt	Alexandria university	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (15)

Ben-Meir A, Aboo-Dia M, Revel A, Eizenman E, Laufer N, Simon A. The benefit of human chorionic gonadotropin supplementation throughout the secretory phase of frozen-thawed embryo transfer cycles. Fertil Steril. 2010 Feb;93(2):351-4. doi: 10.1016/j.fertnst — View Citation

Deng L, Chen X, Blockeel C, Ye DS, Chen SL. Intramuscular injection of human chorionic gonadotropin prior to secretory transformation in patients undergoing frozen-thawed embryo transfer cycles. Reprod Biol Endocrinol. 2020 May 25;18(1):52. doi: 10.1186/s12958-020-00606-y. — View Citation

Eftekhar M, Rahmani E, Eftekhar T. Effect of adding human chorionic gonadotropin to the endometrial preparation protocol in frozen embryo transfer cycles. Int J Fertil Steril. 2012 Oct;6(3):175-8. Epub 2012 Dec 17. Erratum in: Int J Fertil Steril. 2021 Oc — View Citation

Gao M, Jiang X, Li B, Li L, Duan M, Zhang X, Tian J, Qi K. Intrauterine injection of human chorionic gonadotropin before embryo transfer can improve in vitro fertilization-embryo transfer outcomes: a meta-analysis of randomized controlled trials. Fertil Steril. 2019 Jul;112(1):89-97.e1. doi: 10.1016/j.fertnstert.2019.02.027. Review. — View Citation

Hatoum I, Bellon L, Swierkowski N, Ouazana M, Bouba S, Fathallah K, Paillusson B, Bailly M, Boitrelle F, Alter L, Bergère M, Selva J, Wainer R. Disparities in reproductive outcomes according to the endometrial preparation protocol in frozen embryo transfe — View Citation

Jing S, Li XF, Zhang S, Gong F, Lu G, Lin G. Increased pregnancy complications following frozen-thawed embryo transfer during an artificial cycle. J Assist Reprod Genet. 2019 May;36(5):925-933. doi: 10.1007/s10815-019-01420-1. Epub 2019 Mar 29. — View Citation

Laokirkkiat P, Thanaboonyawat I, Boonsuk S, Petyim S, Prechapanich J, Choavaratana R. Increased implantation rate after intrauterine infusion of a small volume of human chorionic gonadotropin at the time of embryo transfer: a randomized, double-blind controlled study. Arch Gynecol Obstet. 2019 Jan;299(1):267-275. doi: 10.1007/s00404-018-4962-7. Epub 2018 Nov 17. — View Citation

Lawrenz B, Coughlan C, Melado L, Fatemi HM. The ART of frozen embryo transfer: back to nature! Gynecol Endocrinol. 2020 Jun;36(6):479-483. doi: 10.1080/09513590.2020.1740918. Epub 2020 Mar 18. Review. — View Citation

Licht P, Fluhr H, Neuwinger J, Wallwiener D, Wildt L. Is human chorionic gonadotropin directly involved in the regulation of human implantation? Mol Cell Endocrinol. 2007 Apr 15;269(1-2):85-92. Epub 2007 Feb 14. Review. — View Citation

Licht P, von Wolff M, Berkholz A, Wildt L. Evidence for cycle-dependent expression of full-length human chorionic gonadotropin/luteinizing hormone receptor mRNA in human endometrium and decidua. Fertil Steril. 2003 Mar;79 Suppl 1:718-23. — View Citation

Makrigiannakis A, Vrekoussis T, Zoumakis E, Kalantaridou SN, Jeschke U. The Role of HCG in Implantation: A Mini-Review of Molecular and Clinical Evidence. Int J Mol Sci. 2017 Jun 19;18(6). pii: E1305. doi: 10.3390/ijms18061305. Review. — View Citation

Shiotani M, Matsumoto Y, Okamoto E, Yamada S, Mizusawa Y, Furuhashi K, Ogata H, Ogata S, Kokeguchi S. Is human chorionic gonadotropin supplementation beneficial for frozen and thawed embryo transfer in estrogen/progesterone replacement cycles?: A randomized clinical trial. Reprod Med Biol. 2017 Apr 4;16(2):166-169. doi: 10.1002/rmb2.12023. eCollection 2017 Apr. — View Citation

Srivastava A, Sengupta J, Kriplani A, Roy KK, Ghosh D. Profiles of cytokines secreted by isolated human endometrial cells under the influence of chorionic gonadotropin during the window of embryo implantation. Reprod Biol Endocrinol. 2013 Dec 17;11:116. d — View Citation

Tan H, Hu S; Qiongyu , Chen Y, Jin L, Wu C. The Effect of Intrauterine Administration of Human Chorionic Gonadotropin (hCG) Before Embryo Transfer During Assisted Reproductive Cycles: a Meta-Analysis of Randomized Controlled Trials. Geburtshilfe Frauenheilkd. 2019 Jul;79(7):713-722. doi: 10.1055/a-0837-3246. Epub 2019 Apr 1. — View Citation

Tesarik J, Hazout A, Mendoza C. Luteinizing hormone affects uterine receptivity independently of ovarian function. Reprod Biomed Online. 2003 Jul-Aug;7(1):59-64. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth delivery rate (LBR)	Number of live births beyond 28 weeks of gestational age to the total number of FET cycles	7 months
Secondary	Clinical pregnancy rate	number of cases with observed gestational sac with embryonic heartbeat detected by ultrasound two weeks after positive pregnancy to the totoal number of frozen embryo transfer cycles.	2 weeks after positive pregnancy test
Secondary	Implantation rate	proportion of the number of gestational sacs to the number of embryos transferred	2 weeks after positive pregnancy test
Secondary	Miscarriage rate	number of lost before the 20th week of gestation to the number of clinical pregnancies	20 weeks gestational age