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

4 mars 2021 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Förenade arabemiraten
- - Abu Dhabi, Förenade arabemiraten, 60202
    - IVI Middle East Fertility Clinic

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 42 år (Vuxen)

Tar emot friska volontärer

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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).

Grupp / Kohort

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).

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Ongoing pregnancy rate to 8 weeks gestation Tidsram: 8 weeks	viable pregnancy to 8 gestational weeks	8 weeks
Pregnancy rate beta human chorionic gonadotropin (ß-hCG) > 5 IU Tidsram: 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 Tidsram: 5 weeks	Positive ß-hCG, but at 5 gestational weeks no ultrasonographic visible gestational sac seen	5 weeks
Clinical implantation rate Tidsram: 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 Tidsram: 5 weeks	Ultrasonographic visible sac at 5 gestational weeks	5 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

ART Fertility Clinics LLC

Utredare

Huvudutredare: Carol Coughlan, PhD, IVI Middle East Fertility Clinic LLC

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 juni 2019

Primärt slutförande (Faktisk)

15 juli 2020

Avslutad studie (Faktisk)

30 juli 2020

Studieregistreringsdatum

Först inskickad

15 maj 2019

Först inskickad som uppfyllde QC-kriterierna

16 maj 2019

Första postat (Faktisk)

17 maj 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 mars 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 mars 2021

Senast verifierad

1 mars 2021

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

1901-ABU-015-CC

Plan för individuella deltagardata (IPD)

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Läkemedels- och apparatinformation, studiedokument

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