Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
NCT ID: NCT05969795
Last Updated: 2025-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
342 participants
INTERVENTIONAL
2023-09-05
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Study Group
Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Blood for P4 measurement will be drawn upon admission to the clinic for the ET procedure. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure.
Transvaginal ultrasound
Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
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).
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.
Embryo transfer
The procedure in which embryo is placed in the uterus.
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)
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
Control Group
Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Administer on FET day 200 mg of P4 and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. Blood for P4 measurement will be drawn before starting LPS in form of vaginal progesterone. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy.
Transvaginal ultrasound
Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
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).
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
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
Embryo transfer
The procedure in which embryo is placed in the uterus.
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)
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
Interventions
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Transvaginal ultrasound
Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
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).
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
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
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.
Embryo transfer
The procedure in which embryo is placed in the uterus.
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)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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….)
18 Years
40 Years
FEMALE
Yes
Sponsors
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ART Fertility Clinics LLC
OTHER
Responsible Party
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Barbara Lawrenz
Scientific Director
Principal Investigators
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Barbara Lawrenz, PhD
Role: PRINCIPAL_INVESTIGATOR
ART Fertility Clinics LLC
Locations
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ART Fertility Clinics LLC
Abu Dhabi, , United Arab Emirates
ART Fertility Clinics Al Ain
Al Ain City, , United Arab Emirates
ART Fertility Clinics Dubai
Dubai, , United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Practice Committee of the American Society for Reproductive Medicine. The clinical relevance of luteal phase deficiency: a committee opinion. Fertil Steril. 2012 Nov;98(5):1112-7. doi: 10.1016/j.fertnstert.2012.06.050. Epub 2012 Jul 20.
von Versen-Hoynck F, Schaub AM, Chi YY, Chiu KH, Liu J, Lingis M, Stan Williams R, Rhoton-Vlasak A, Nichols WW, Fleischmann RR, Zhang W, Winn VD, Segal MS, Conrad KP, Baker VL. Increased Preeclampsia Risk and Reduced Aortic Compliance With In Vitro Fertilization Cycles in the Absence of a Corpus Luteum. Hypertension. 2019 Mar;73(3):640-649. doi: 10.1161/HYPERTENSIONAHA.118.12043.
Related Links
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Shapiro BS, Garner FC, Aguirre M. The Freeze-All Cycle: A New Paradigm Shift in ART. In Nagy ZP, Varghese AC, Agarwal A, editors. In Vitro Fertilization \[Internet\] 2019;, p. 765-778. Springer International Publishing
Other Identifiers
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2306-ABU-009-BL
Identifier Type: -
Identifier Source: org_study_id
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