Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
1 other identifier
interventional
342
1 country
3
Brief Summary
To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2023
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedStudy Start
First participant enrolled
September 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
ExpectedJanuary 9, 2025
January 1, 2025
2.7 years
July 24, 2023
January 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Implantation rate
Number of embryos which have produced ultrasonographic evidence of an intrauterine gestational sac per the total number of embryos transferred into the uterine cavity (Zegers-Hochschild et al., 2009).
2 months
Clinical pregnancy rate
hCG \> 15 Iu/ml and ultrasound confirmation of a gestational sac
2 months
Live birth rate
Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009)
41 weeks
Serum P4 levels on ET day
Progesterone level on the day of embryo transfer
1 day
Serum E2 and P4 levels on day 5 or 6 after ET procedure
Estradiol and Progesterone levels on day 5 or 6 after embryo transfer
6 days
Serum E2 and P4 levels on day 10 after ET procedure
Estradiol and Progesterone levels on day 10 after embryo transfer
10 days
Study Arms (2)
Study Group
OTHERIntermittent 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.
Control Group
OTHERIntermittent 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.
Interventions
Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
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).
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 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure
Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.
The procedure in which embryo is placed in the uterus.
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 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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….)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
ART Fertility Clinics LLC
Abu Dhabi, 60202, United Arab Emirates
ART Fertility Clinics Al Ain
Al Ain City, United Arab Emirates
ART Fertility Clinics Dubai
Dubai, United Arab Emirates
Related Publications (10)
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: 36171152BACKGROUNDCsapo 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: 341008BACKGROUNDFilicori 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: 6427277BACKGROUNDGinstrom 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: 30910545BACKGROUNDPape 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: 36308939BACKGROUNDRoelens 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: 36273850BACKGROUNDSoules 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: 3357651BACKGROUNDSu 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: 34730071BACKGROUNDPractice 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.
PMID: 22819186BACKGROUNDvon 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.
PMID: 30636552BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara Lawrenz, PhD
ART Fertility Clinics LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientific Director
Study Record Dates
First Submitted
July 24, 2023
First Posted
August 1, 2023
Study Start
September 5, 2023
Primary Completion
April 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
January 9, 2025
Record last verified: 2025-01