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Progesterone Induced Endometrial ReceptivityNCT02788097

Comparison of Day 19 and Day 20 Artificial FET

A study testing Progesterone supplementation in people with Progesterone Induced Endometrial Receptivity, run by Antalya IVF at 1 site in Turkey (Türkiye).

Terminated

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

Official record
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Trial summary

In recent artificial frozen embryo transfers (FET) in which blastocysts vitrified on day 4 of culture and transferred on P+4, with blastocysts traditionally transferred on P+5, a high rate of implantation has been observed. Read more about this study

Who is it for?
Ages 19 to 42 years, women only
What is being tested?
Progesterone supplementation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteTurkey (Türkiye)
Study dates
May 2016to Oct 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 19 to 42 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • a freeze-all cycle

Who cannot join

  • patients who do not consent
  • patients who retract their consent
  • patients with day 4 blastocysts frozen
  • patients with no blastocysts frozen

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Antalya IVF

    Antalya, Antalya, 07080

Other trials in Turkey (Türkiye)

About this study

Official title: Assessment of Artificial FET Reproductive Outcomes: Transfer of Blastocysts on Progesterone + 4 Versus Progesterone + 5

In recent artificial frozen embryo transfers (FET) in which blastocysts vitrified on day 4 of culture and transferred on P+4, with blastocysts traditionally transferred on P+5, a high rate of implantation has been observed. In addition, a greater number of these implantations resulted in clinical pregnancies (i.e., a conceptus with normal fetal heart activity). In this prospective randomised control study, the investigators will investigate whether this increased viability, is due either to embryo quality, endometrial receptivity, or a combination of the two factors by randomizing the transfer of day 5 blastocysts to P+4 or P+5.

Read the detailed description

During the first 20 years of IVF embryo transfers were performed on days 1 to 3, even though evidence suggested that embryos dispelled into the uterus from fallopian tubes were at a post-compaction stage. This meant that initially all embryo transfers were asynchronous transfers. This strategy was imposed upon IVF by the vitro culture conditions of the time, which were sub-optimal for normal rates of blastocyst development. Transferred asynchronously cleavage stage embryos have to adapt to "alien" non- physio-metabolic conditions that may result in embryonic stress and compromised embryo development. In fresh embryo transfer this is further exacerbated by the supraphysiological hormone effects of controlled ovarian stimulation. In addition, there are mechanical factors (i.e. uterine contractility) and time factors, related to the endometrium (i.e., window of implantation) and embryo (i.e., time to hatching), that may reduce the chances of implantation. In contrast, to most other mammalian species the transfer of cleavage stage embryos to human uteruses led to acceptable levels of pregnancy and live birth.

The regulation of synchrony between embryo and endometrium has not been fully addressed clinically in the human. This limitation affects IVF significantly in that up to 30% of embryo transfers may be affected by endometrial receptivity factors. The endometrium is a highly specialized, hormonally regulated tissue which is only receptive to embryo communication/interaction for a self-limiting period referred to as the window of implantation. Currently, there is no way to non-invasively determine the time of optimal receptivity, with IVF transfers performed on the assumption that the WOI was sufficiently wide enough to accommodate implantation in most patients and most treatments. During this period, the endometrial epithelium acquires optimal receptivity by progressing through specific structural, functional, and morphological changes induced by pre-ovulatory estrogen and progesterone and post-ovulatory progesterone, LH, and hCG.

During the last three decades, there has been a major increase in the understanding of embryo physiology and correspondingly major improvements in the in vitro culture technologies used, in particular culture media and incubator technologies. These improvements have resulted in the culture of more good quality cleavage stage embryos and consequently blastocysts after extended culture, increasing embryo utility and the pregnancy capacity of an cycle. The increased implantation rates obtained with blastocyst transfers may be as much to do with embryo quality and stage, i.e., blastocysts have the required bi-directional communication competency needed for implantation, as with the WOI, i.e., the time of blastocyst formation and transfer coincides with the WOI of endometria. Moreover, the presently improved culture conditions may also be changing traditional embryo developmental milestones, in particular, the time to blastulation may be decreasing. An increasing number of blastocysts are being formed on day 4 of culture - ±100 hours post-insemination. Traditionally, day 4 embryos were only assessed for evidence of compaction, which is the developmental stage leading to blastulation and cell differentiation.

Zygotes or embryos that reach developmental milestones first (i.e., syngamy, early cleavage, early compaction and early blastulation) are generally believed to have increased chances of normal developmental potential. In recent artificial frozen embryo transfers (FET) in which blastocysts vitrified on day 4 of culture and transferred on P+4, with blastocysts traditionally transferred on P+5, a high rate of implantation has been observed. In addition, a greater number of these implantations resulted in clinical pregnancies (i.e., a conceptus with normal fetal heart activity). In this prospective randomised control study, the investigators will investigate whether this increased viability, is due either to embryo quality, endometrial receptivity, or a combination of the two factors by randomizing the transfer of day 5 blastocysts to P+4 or P+5.

Being tested
Progesterone supplementation
Keywords
blastocysts, progesterone, implantation, artificial frozen embryo transfer

What participants receive

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

  • Progesterone supplementationProcedure or surgery

    artificial frozen embryo transfers

Study groups in NCT02788097
Study groupRoleWhat they receive
Progesterone + 4Experimentalthe transfer of day 5 blastocyst on the 5th day of progesterone supplementation
Receives: Procedure: Progesterone supplementation
Progesterone + 5Active comparatorthe transfer of day 5 blastocysts on the 6th day of progesterone supplementation
Receives: Procedure: Progesterone supplementation

What is being measured

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

  1. Biochemical Pregnancy

    >30IU/L of serum βhCG on day 14 of cycle

    Measured: 1 year

Timeline

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

  1. First posted2 Jun 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionOct 2016
  4. Study completionOct 2016

Why it stopped: Large and sustained difference in pregnancy rate

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 N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02788097
Sponsor's protocol ID
AntalyaIVF
Status last verified
Dec 2016
First submitted
25 May 2016
Last updated
3 Feb 2017
Data monitoring committee
No
Individual data sharing
Yes: data to be entered

Publications

  • Fauser BC, Devroey P. Reproductive biology and IVF: ovarian stimulation and luteal phase consequences. Trends Endocrinol Metab. 2003 Jul;14(5):236-42. doi: 10.1016/s1043-2760(03)00075-4.

    PubMed 12826330
  • van de Vijver A, Polyzos NP, Van Landuyt L, Mackens S, Stoop D, Camus M, De Vos M, Tournaye H, Blockeel C. What is the optimal duration of progesterone administration before transferring a vitrified-warmed cleavage stage embryo? A randomized controlled trial. Hum Reprod. 2016 May;31(5):1097-104. doi: 10.1093/humrep/dew045. Epub 2016 Mar 22.

    PubMed 27005893
  • Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.

    PubMed 21502182

Questions about this trial

What is this clinical trial studying?

A study testing Progesterone supplementation in people with Progesterone Induced Endometrial Receptivity, run by Antalya IVF at 1 site in Turkey (Türkiye).

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 1 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: stopped early, as of the sponsor's last update on 3 Feb 2017. 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 Turkey (Türkiye). 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?

Yes. Results are posted in the registry (first posted 8 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Biochemical Pregnancy (time frame: 1 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 NCT02788097, which also lists 3 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 3 Feb 2017.

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