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

NCT05340010 | Completed Phase 4

• 1 other identifier: HCG in FET cycles
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

hCG; FET; Frozen-thawed Embryo Transfe; Human Chorionic Gonadotrophin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical pregnancy rate

  2 weeks after positive pregnancy test

• Implantation rate

  2 weeks after positive pregnancy test

• Miscarriage rate

  20 weeks gestational age

Study Arms (2)

HCG group

EXPERIMENTAL

n Group 1 (hCG): participants will receive endometrial preparation with estrogen and an intramuscular hCG injection will before progesterone supplementation

Drug: Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU

control group

NO INTERVENTION

Group 2 (control): participants will receive the conventional endometrial preparation with estrogen followed by progesterone supplementation

Interventions

Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU DRUG

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

HCG group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient age ≤ 38 years.
• Normal 3D transvaginal ultrasound.
• At least two good quality embryos cryopreserved by vitrification.
• No GnRH agonists administration before FET cycle.

You may not qualify if:

• Endometriosis.
• Uterine anomalies.
• Evidence of hydrosalpinx by hystrosalpingography or ultrasound.
• Evidence of immune disease, hematological or hormonal disorder.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria university

Alexandria, Egypt

Location

Related Publications (15)

• 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. doi: 10.1016/j.mce.2006.09.016. Epub 2007 Feb 14.

  PMID: 17367920 BACKGROUND

• 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.

  PMID: 31303659 BACKGROUND

• 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.

  PMID: 31277770 BACKGROUND

• 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. doi: 10.1016/s1472-6483(10)61729-4.

  PMID: 12930575 BACKGROUND

• 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.

  PMID: 30449012 BACKGROUND

• 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.

  PMID: 29259465 BACKGROUND

• 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.

  PMID: 32450894 BACKGROUND

• 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.

  PMID: 32188299 RESULT

• 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.fertnstert.2009.02.027. Epub 2009 Apr 1.

  PMID: 19342020 RESULT

• 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.

  PMID: 24520435 RESULT

• 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.

  PMID: 30924053 RESULT

• Hatoum I, Bellon L, Swierkowski N, Ouazana M, Bouba S, Fathallah K, Paillusson B, Bailly M, Boitrelle F, Alter L, Bergere M, Selva J, Wainer R. Disparities in reproductive outcomes according to the endometrial preparation protocol in frozen embryo transfer : The risk of early pregnancy loss in frozen embryo transfer cycles. J Assist Reprod Genet. 2018 Mar;35(3):425-429. doi: 10.1007/s10815-017-1078-0. Epub 2017 Nov 6.

  PMID: 29110260 RESULT

• 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. doi: 10.1186/1477-7827-11-116.

  PMID: 24345207 RESULT

• 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):1305. doi: 10.3390/ijms18061305.

  PMID: 28629172 RESULT

• 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. doi: 10.1016/s0015-0282(02)04822-7.

  PMID: 12620482 RESULT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: April 21, 2022
• Study Start: January 1, 2020
• Primary Completion: June 20, 2022
• Study Completion: July 30, 2022
• Last Updated: September 1, 2022

Record last verified: 2021-12

Locations

EG (1)