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Unrecognized ConditionNCT05478616

Expression of Endometrium During Window of Implantation

An observational study of Unrecognized Condition, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The aim of this study was to investigate the expression of endometrium during window of implantation between natural cycles and artificial cycles. Read more about this study

Who is it for?
Ages 30 to 44 years, women only
Conditions the study is for
Unrecognized Condition
How many people
3 participants
Where
1 siteTaiwan
Study dates
1 Jul 2022to 31 Dec 2023
Phase
Observational
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 30 to 44 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Infertile women aged 30-44 years with implantation failure at least two times

Who may be able to join

  • Age: 30-44 years
  • BMI: 18~30 kg/m2
  • Implantation failure at least two times

Who cannot join

  • Primary ovarian insufficiency
  • Congenital uterine anomaly
  • Severe intrauterine adhesion
  • Malignancy
  • Donor cycle

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

Other trials in Taiwan

About this study

Official title: To Investigate the Expression of Endometrium During Window of Implantation Between Natural Cycles and Artificial Cycles

The aim of this study was to investigate the expression of endometrium during window of implantation between natural cycles and artificial cycles.

Read the detailed description

Due to progress of embryo vitrification in recent years, frozen embryo transfer (FET) of in vitro fertilization (IVF) has already been a world trend. The most used two protocols of FET are natural cycles (NCs) and artificial cycles (ACs). Recent studies showed that IVF outcomes of NCs were superior to ACs. We hypothesized that the result may be because of better endometrial receptivity of NCs compared to ACs. In NCs, no hormonal agents were administrated. Thus, endometrial receptivity was not disturbed by hormone and became better. However, there were few studies to explore the issue. Therefore, the aim of this study was to investigate the expression of endometrium during window of implantation (WOI) between NCs and ACs.

The study will be performed from July 1st, 2022 to December 31th, 2023 in our reproductive center. We plan to enroll 60 infertile women who have underwent IVF cycles and would like to receive endometrial receptivity assay. We divide the participants into two groups, NCs and ACs. In NCs, no hormonal agents will be used. We identify ovulation day via serial hormone data and sample endometrium during WOI (LH surge + 7 days). In ACs, first, estrogen will be given for 10~14 days and then transvaginal sonography will be conducted. When endometrial thickness reaches 8 mm at least, progesterone will be prescribed. Endometrium is sampled during WOI (P4 + 5 days). We will record basic characteristics, infertility history, hormone data, ovarian reserve and endometrial thickness of infertile women in both groups. Endometrial samples will be assessed miRNA, implantation factors, uterine NK cells and T cells in both groups.

Keywords
window of implantation, endometrium receptivity, frozen embryo transfer cycles, natural cycles, artificial cycles, hormone replacement therapy cycles

What participants receive

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

Study groups in NCT05478616
Study groupRoleWhat they receive
Natural cyclesEndometrium will be sampled at the day of LH surge + 7 days.
Artificial cyclesEndometrium will be sampled at the day of P4 + 5 days.

What is being measured

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

  1. Expression of endometrium

    miRNA

    Measured: through study completion, an average of 1.5 year

Secondary outcomes (2)

  1. Implantation factors of endometrium

    HOXA10

    Measured: through study completion, an average of 1.5 year

  2. Immune cells of endometrium

    Uterine NK cells

    Measured: through study completion, an average of 1.5 year

Timeline

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

  1. First posted28 Jul 2022
  2. Study start1 Jul 2022
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Why it stopped: difficult to recruit patients

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05478616
Sponsor's protocol ID
KSVGH22-CT7-07
Status last verified
Aug 2024
First submitted
26 Jul 2022
Last updated
5 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Teh WT, McBain J, Rogers P. What is the contribution of embryo-endometrial asynchrony to implantation failure? J Assist Reprod Genet. 2016 Nov;33(11):1419-1430. doi: 10.1007/s10815-016-0773-6. Epub 2016 Aug 1.

    PubMed 27480540

  • Bellver J, Simon C. Implantation failure of endometrial origin: what is new? Curr Opin Obstet Gynecol. 2018 Aug;30(4):229-236. doi: 10.1097/GCO.0000000000000468.

    PubMed 29889670

  • Neves AR, Devesa M, Martinez F, Garcia-Martinez S, Rodriguez I, Polyzos NP, Coroleu B. What is the clinical impact of the endometrial receptivity array in PGT-A and oocyte donation cycles? J Assist Reprod Genet. 2019 Sep;36(9):1901-1908. doi: 10.1007/s10815-019-01535-5. Epub 2019 Jul 27.

    PubMed 31352621

  • Cozzolino M, Diaz-Gimeno P, Pellicer A, Garrido N. Evaluation of the endometrial receptivity assay and the preimplantation genetic test for aneuploidy in overcoming recurrent implantation failure. J Assist Reprod Genet. 2020 Dec;37(12):2989-2997. doi: 10.1007/s10815-020-01948-7. Epub 2020 Sep 24.

    PubMed 32974805

  • Simon C, Gomez C, Cabanillas S, Vladimirov I, Castillon G, Giles J, Boynukalin K, Findikli N, Bahceci M, Ortega I, Vidal C, Funabiki M, Izquierdo A, Lopez L, Portela S, Frantz N, Kulmann M, Taguchi S, Labarta E, Colucci F, Mackens S, Santamaria X, Munoz E, Barrera S, Garcia-Velasco JA, Fernandez M, Ferrando M, Ruiz M, Mol BW, Valbuena D; ERA-RCT Study Consortium Group. A 5-year multicentre randomized controlled trial comparing personalized, frozen and fresh blastocyst transfer in IVF. Reprod Biomed Online. 2020 Sep;41(3):402-415. doi: 10.1016/j.rbmo.2020.06.002. Epub 2020 Jun 15.

    PubMed 32723696

  • Bergin K, Eliner Y, Duvall DW Jr, Roger S, Elguero S, Penzias AS, Sakkas D, Vaughan DA. The use of propensity score matching to assess the benefit of the endometrial receptivity analysis in frozen embryo transfers. Fertil Steril. 2021 Aug;116(2):396-403. doi: 10.1016/j.fertnstert.2021.03.031. Epub 2021 Apr 27.

    PubMed 33926718

  • Riestenberg C, Kroener L, Quinn M, Ching K, Ambartsumyan G. Routine endometrial receptivity array in first embryo transfer cycles does not improve live birth rate. Fertil Steril. 2021 Apr;115(4):1001-1006. doi: 10.1016/j.fertnstert.2020.09.140. Epub 2021 Jan 15.

    PubMed 33461752

  • Rienzi L, Gracia C, Maggiulli R, LaBarbera AR, Kaser DJ, Ubaldi FM, Vanderpoel S, Racowsky C. Oocyte, embryo and blastocyst cryopreservation in ART: systematic review and meta-analysis comparing slow-freezing versus vitrification to produce evidence for the development of global guidance. Hum Reprod Update. 2017 Mar 1;23(2):139-155. doi: 10.1093/humupd/dmw038.

    PubMed 27827818

  • Roque M, Haahr T, Geber S, Esteves SC, Humaidan P. Fresh versus elective frozen embryo transfer in IVF/ICSI cycles: a systematic review and meta-analysis of reproductive outcomes. Hum Reprod Update. 2019 Jan 1;25(1):2-14. doi: 10.1093/humupd/dmy033.

    PubMed 30388233

  • Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.

    PubMed 33539543

  • Mackens S, Santos-Ribeiro S, van de Vijver A, Racca A, Van Landuyt L, Tournaye H, Blockeel C. Frozen embryo transfer: a review on the optimal endometrial preparation and timing. Hum Reprod. 2017 Nov 1;32(11):2234-2242. doi: 10.1093/humrep/dex285.

    PubMed 29025055

  • Shaodi Z, Qiuyuan L, Yisha Y, Cuilian Z. The effect of endometrial thickness on pregnancy outcomes of frozen-thawed embryo transfer cycles which underwent hormone replacement therapy. PLoS One. 2020 Sep 24;15(9):e0239120. doi: 10.1371/journal.pone.0239120. eCollection 2020.

    PubMed 32970718

  • Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.

    PubMed 23820515

  • 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

  • Liu X, Shi W, Shi J. Natural cycle frozen-thawed embryo transfer in young women with regular menstrual cycles increases the live-birth rates compared with hormone replacement treatment: a retrospective cohort study. Fertil Steril. 2020 Apr;113(4):811-817. doi: 10.1016/j.fertnstert.2019.11.023. Epub 2020 Mar 5.

    PubMed 32147171

Questions about this trial

What is this clinical trial studying?

An observational study of Unrecognized Condition, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Aug 2024. 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 Taiwan. 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.

Are results available for this study?

The study was stopped early (reason given: difficult to recruit patients). Results are not available in the source record.

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?

Expression of endometrium (time frame: through study completion, an average of 1.5 year). 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 NCT05478616, which also lists 22 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 5 Aug 2024.

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