Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support

Официальное название

Comparison of Live Birth Rate (> 24 Weeks) in Natural Cycle (NC) Single Euploid Frozen Embryo Transfers (FET) With Versus Without Luteal Phase Support (LPS)

Обзор

To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.

Подробное описание

In case the study will show that the live birth rate in single euploid NC frozen embryo transfer cycles without LPS is not inferior to NC cycles with LPS, treatment can be simplified, and participants comfort can be increased.

Вмешательства

• Диагностический тест Transvaginal ultrasound
  Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
• Диагностический тест Serial serum LH, E2, P4
  Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng/ml (Irani et al., 2017).
• Препарат Progesterone 100 Mg Vaginal Insert
  On day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy
• Диагностический тест Serum P4 day of ET - Control Group
  Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure
• Диагностический тест Serum P4 day of ET - Study Group
  Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.
• Процедура Embryo transfer
  The procedure in which embryo is placed in the uterus.
• Диагностический тест Serum hCG 10 days after ET
  Pregnancy will be confirmed / excluded by measurement of serum hCG 10 days after ET procedure and a level of \> 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006)
• Диагностический тест Serum P4 10 days after ET
  Serum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure

Первичные конечные точки

• Implantation rate [Срок оценки: 2 months]
• Clinical pregnancy rate [Срок оценки: 2 months]
• Live birth rate [Срок оценки: 41 weeks]
• Serum P4 levels on ET day [Срок оценки: 1 day]
• Serum E2 and P4 levels on day 5 or 6 after ET procedure [Срок оценки: 6 days]
• Serum E2 and P4 levels on day 10 after ET procedure [Срок оценки: 10 days]

Критерии участия

Критерии включения

• Age: 18 to 40 years
• Regular ovulatory cycles
• Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on day 5 or day 6
• Detection of ovulation by P4 rise > 1.0 ng/ml after LH surge
• P4 value of at least 5 ng/ml on day 4 after ovulation

Критерии исключения

• History of repeated pre-menstrual spotting
• Factors affecting the implantation through anatomical changes of the uterus / ovaries or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids / polyps, isthmocele with intracavitary fluid presence, hydrosalpinx….)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

ОАЭ · 3 центра

• ART Fertility Clinics LLC — Abu Dhabi
• ART Fertility Clinics Al Ain — Al Ain City
• ART Fertility Clinics Dubai — Dubai

Публикации

• Bortoletto P, Prabhu M, Baker VL. Association between programmed frozen embryo transfer and hypertensive disorders of pregnancy. Fertil Steril. 2022 Nov;118(5):839-848. doi: 10.1016/j.fertnstert.2022.07.025. Epub 2022 Sep 25. PMID 36171152
• Csapo AI, Pulkkinen M. Indispensability of the human corpus luteum in the maintenance of early pregnancy. Luteectomy evidence. Obstet Gynecol Surv. 1978 Feb;33(2):69-81. doi: 10.1097/00006254-197802000-00001. No abstract available. PMID 341008
• Filicori M, Butler JP, Crowley WF Jr. Neuroendocrine regulation of the corpus luteum in the human. Evidence for pulsatile progesterone secretion. J Clin Invest. 1984 Jun;73(6):1638-47. doi: 10.1172/JCI111370. PMID 6427277
• Ginstrom Ernstad E, Wennerholm UB, Khatibi A, Petzold M, Bergh C. Neonatal and maternal outcome after frozen embryo transfer: Increased risks in programmed cycles. Am J Obstet Gynecol. 2019 Aug;221(2):126.e1-126.e18. doi: 10.1016/j.ajog.2019.03.010. Epub 2019 Mar 22. PMID 30910545
• Pape J, Levy J, von Wolff M. Early pregnancy complications after frozen-thawed embryo transfer in different cycle regimens: A retrospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2022 Dec;279:102-106. doi: 10.1016/j.ejogrb.2022.10.015. Epub 2022 Oct 21. PMID 36308939
• Roelens C, Blockeel C. Impact of different endometrial preparation protocols before frozen embryo transfer on pregnancy outcomes: a review. Fertil Steril. 2022 Nov;118(5):820-827. doi: 10.1016/j.fertnstert.2022.09.003. PMID 36273850
• Soules MR, Clifton DK, Steiner RA, Cohen NL, Bremner WJ. The corpus luteum: determinants of progesterone secretion in the normal menstrual cycle. Obstet Gynecol. 1988 May;71(5):659-66. PMID 3357651
• Su S, Zeng M, Duan J. Luteal phase support for natural cycle frozen embryo transfer: a meta-analysis. Gynecol Endocrinol. 2022 Feb;38(2):116-123. doi: 10.1080/09513590.2021.1998438. Epub 2021 Nov 3. PMID 34730071

Идентификаторы

NCT: NCT05969795 · 2306-ABU-009-BL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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