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What is the Optimal Cycle Regimen for Frozen- Thawed Embryo Transfer Cycles

4. marts 2021 opdateret af: Prof Dr. Human Fatemi, ART Fertility Clinics LLC

What is the Optimal Cycle Regimen for Frozen- Thawed Embryo Transfer Cycles: Spontaneous Natural Cycles Versus Hormonal Replacement Treatment (HRT) Cycles

Investigators will be comparing artificial (HRT) frozen-thawed embryo transfer cycles to correctly conducted spontaneous natural cycles after the transfer of a chromosomally normal embryo.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The most common treatment protocols for frozen embryo transfers include natural cycles with or without human chorionic gonadotrophin (HCG) trigger or endometrial preparation with hormonal treatment (artificial cycles), with or without Gonadotrophin - releasing hormone agonist suppression. Recent studies comparing artificial and natural cycles concluded that the optimal means of endometrial preparation for frozen- thawed cycle remains unclear and both options may be offered to women with regular ovulatory cycles.

Correctly identified spontaneous natural cycles are the preferred option for frozen-thawed embryo transfer in women with regular menstrual cycles.

Investigators will be comparing artificial (HRT) frozen-thawed embryo transfer cycles to correctly conducted spontaneous natural cycles after the transfer of a chromosomally normal embryo.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Arabiske Emirater
- - Abu Dhabi, Forenede Arabiske Emirater, 60202
    - IVI Middle East Fertility Clinic

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 42 år (Voksen)

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Female who underwent a previous ovarian stimulation for In Vitro Fertilisation/Intracytoplasmic Sperm Injection with pre-implantation genetic screening and embryo vitrification, who are planned for their first frozen thaw embryo transfer cycle

Beskrivelse

Inclusion criteria include the following:

Women aged 18 years to 42 years with regular menses (26-34 days)
Having 1 or 2 chromosomally normal cryopreserved blastocysts available for transfer.
First frozen-thawed transfer cycle
Progesterone level < 1.5 ng/mL day of trigger injection in stimulation cycle from which embryos to be transferred were created.

Exclusion criteria include the following:

Polycystic ovarian syndrome
Poor ovarian responder in accordance with Bologna criteria
Uterine abnormality US / saline infusion sonohysterogram
Previous dilatation & curettage (D&C)
Hydrosalpinx
Asherman syndrome
History of endometriosis
ICSI due to severe male factor with testicular sperm
Any known contraindications or allergy to oral estradiol or progesterone.
Discontinuation of HRT medication ( medication error in research HRT cycle )
Failure to detect ovulation in the research natural cycle
Duration of estradiol exposure ≥ 17 days and endometrium < 6mm
Spontaneous ovulation in HRT artificial cycle

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
Artificial (HRT) Cycles Commence estradiol valerate (E2) 4mg from day 2 or 3 of period for 3 days Increase E2 to 6mg on day 4 of E2 treatment, according to clinician discretion based on endometrial thickness. Transvaginal scan throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of a dominant follicle on the ovaries. Serial measurements of serum LH (luteinizing hormone), estradiol and progesterone levels. Initial progesterone dose of 100mg at 22hrs (vaginal suppository) after ≥ 7 days and ≤ 16 days of estradiol administration when the minimal endometrial thickness achieved is 6mm with a trilaminar appearance. Subsequently increase progesterone administration to 100mg vaginally three times daily. Continue E2 administration 6mg (3 tablets daily). Embryo transfer is scheduled on the 5th full day of progesterone administration.
Spontaneous natural cycles: Day 2 of menses and throughout patients' natural cycle scans to monitor follicular growth. Measurements of serum LH, estradiol and progesterone levels to determine ovulation. The LH surge will be considered to have begun when the concentration rises by 180% above the most recent serum value and continues to rise thereafter (Irani et al. 2017, Fatemi et al., 2010). Day 1 after the LH rise, a decrease in estradiol concentration is identified. Twenty four hours later progesterone concentrations rise with a level of greater than or equal to 1.5ng/mL confirming ovulation (day 0) (Irani et al., 2017; Speroff et al.). This is considered as day 0 with initiation of vaginal progesterone 100mg at 22hrs that night. The following day (day 1) the patient increases progesterone administration to 100mg vaginally 8 hourly and continues until 7 weeks gestation as per clinic protocol. Embryo transfer is scheduled 5 days (day 5) following confirmation of ovulation (day 0).

Gruppe / kohorte

Artificial (HRT) Cycles

Commence estradiol valerate (E2) 4mg from day 2 or 3 of period for 3 days
Increase E2 to 6mg on day 4 of E2 treatment, according to clinician discretion based on endometrial thickness.
Transvaginal scan throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of a dominant follicle on the ovaries.
Serial measurements of serum LH (luteinizing hormone), estradiol and progesterone levels.
Initial progesterone dose of 100mg at 22hrs (vaginal suppository) after ≥ 7 days and ≤ 16 days of estradiol administration when the minimal endometrial thickness achieved is 6mm with a trilaminar appearance.
Subsequently increase progesterone administration to 100mg vaginally three times daily. Continue E2 administration 6mg (3 tablets daily).
Embryo transfer is scheduled on the 5th full day of progesterone administration.

Spontaneous natural cycles:

Day 2 of menses and throughout patients' natural cycle scans to monitor follicular growth.
Measurements of serum LH, estradiol and progesterone levels to determine ovulation.
The LH surge will be considered to have begun when the concentration rises by 180% above the most recent serum value and continues to rise thereafter (Irani et al. 2017, Fatemi et al., 2010).
Day 1 after the LH rise, a decrease in estradiol concentration is identified. Twenty four hours later progesterone concentrations rise with a level of greater than or equal to 1.5ng/mL confirming ovulation (day 0) (Irani et al., 2017; Speroff et al.). This is considered as day 0 with initiation of vaginal progesterone 100mg at 22hrs that night. The following day (day 1) the patient increases progesterone administration to 100mg vaginally 8 hourly and continues until 7 weeks gestation as per clinic protocol. Embryo transfer is scheduled 5 days (day 5) following confirmation of ovulation (day 0).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Ongoing pregnancy rate to 8 weeks gestation Tidsramme: 8 weeks	viable pregnancy to 8 gestational weeks	8 weeks
Pregnancy rate beta human chorionic gonadotropin (ß-hCG) > 5 IU Tidsramme: 12 days	Number of patients with a hCG > 5 IU out of the number of patients who underwent an embryo transfer with one or two euploid embryos	12 days
Biochemical pregnancy rate Tidsramme: 5 weeks	Positive ß-hCG, but at 5 gestational weeks no ultrasonographic visible gestational sac seen	5 weeks
Clinical implantation rate Tidsramme: 6 weeks	Number of gestational sacs observed by ultrasound at 6 weeks of gestation divided by the number of embryos transferred	6 weeks
Clinical pregnancy rate Tidsramme: 5 weeks	Ultrasonographic visible sac at 5 gestational weeks	5 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ART Fertility Clinics LLC

Efterforskere

Ledende efterforsker: Carol Coughlan, PhD, IVI Middle East Fertility Clinic LLC

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juni 2019

Primær færdiggørelse (Faktiske)

15. juli 2020

Studieafslutning (Faktiske)

30. juli 2020

Datoer for studieregistrering

Først indsendt

15. maj 2019

Først indsendt, der opfyldte QC-kriterier

16. maj 2019

Først opslået (Faktiske)

17. maj 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. marts 2021

Sidst verificeret

1. marts 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

1901-ABU-015-CC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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What is the Optimal Cycle Regimen for Frozen- Thawed Embryo Transfer Cycles