AzTrials
AzTrials

hCGPhase 4NCT05340010

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

A Phase 4 study testing Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU in people with hCG and FET, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 38 years, women only
Conditions the study is for
hCG, FET, Frozen-thawed Embryo Transfe
What is being tested?
Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteEgypt
Study dates
1 Jan 2020to 30 Jul 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 38 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Alexandria university

    Alexandria

Other trials in Egypt

About this study

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.

Being tested
Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Chorionic Gonadotrophin Intramuscular injection 10.000 IUDrug

    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

Study groups in NCT05340010
Study groupRoleWhat they receive
HCG groupExperimentaln Group 1 (hCG): participants will receive endometrial preparation with estrogen and an intramuscular hCG injection will before progesterone supplementation
Receives: Drug: Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU
control groupNo interventionGroup 2 (control): participants will receive the conventional endometrial preparation with estrogen followed by progesterone supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live birth delivery rate (LBR)

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

    Measured: 7 months

Secondary outcomes (3)

  1. 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.

    Measured: 2 weeks after positive pregnancy test

  2. Implantation rate

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

    Measured: 2 weeks after positive pregnancy test

  3. Miscarriage rate

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

    Measured: 20 weeks gestational age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2022
  2. Study start1 Jan 2020
  3. Primary completion20 Jun 2022
  4. Study completion30 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05340010
Sponsor's protocol ID
HCG in FET cycles
Status last verified
Dec 2021
First submitted
8 Feb 2022
Last updated
1 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 17367920

  • 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.

    PubMed 31303659

  • 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.

    PubMed 31277770

  • 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.

    PubMed 12930575

  • 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.

    PubMed 30449012

  • 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.

    PubMed 29259465

  • 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.

    PubMed 32450894

  • 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.

    PubMed 32188299

  • 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.

    PubMed 19342020

  • 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.

    PubMed 24520435

  • 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.

    PubMed 30924053

  • 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.

    PubMed 29110260

  • 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.

    PubMed 24345207

  • 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.

    PubMed 28629172

  • 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.

    PubMed 12620482

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU in people with hCG and FET, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth delivery rate (LBR) (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05340010, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.

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