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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT05340010 (opens ClinicalTrials.gov in a new tab)Other idHCG in FET cycles
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
180 participants (actual)
Sponsor
Alexandria University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Egypt

Start
1 Jan 2020
Primary completion
20 Jun 2022
Completion
30 Jul 2022
First posted
21 Apr 2022
Last update posted
1 Sept 2022
Conditions
hCG · FET · Frozen-thawed Embryo Transfe · Human Chorionic Gonadotrophin

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023
  1. Ph 4

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

    NCT05340010

    1 Jan 2020 to 30 Jul 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Human Chorionic Gonadotrophin Intramuscular injection 10.000 IUDrug

Arms2

  • Experimental

    HCG group

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

  • No intervention

    control group

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Live birth delivery rate (LBR)

    Time frame · 7 months

    Registry description

    Number of live births beyond 28 weeks of gestational age to the total number of FET cycles

Secondary outcomes(3)

  1. Clinical pregnancy rate

    Time frame · 2 weeks after positive pregnancy test

    Registry description

    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. Implantation rate

    Time frame · 2 weeks after positive pregnancy test

    Registry description

    proportion of the number of gestational sacs to the number of embryos transferred

  3. Miscarriage rate

    Time frame · 20 weeks gestational age

    Registry description

    number of lost before the 20th week of gestation to the number of clinical pregnancies

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultLawrenz 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
  • ResultBen-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
  • ResultEftekhar 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
  • ResultJing 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
  • ResultHatoum 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
  • ResultSrivastava 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
  • ResultMakrigiannakis 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
  • ResultLicht 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

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 38 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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