Back to resultsComparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
Primary Purpose
Pregnancy Related, Infertility, Female
Status
Not yet recruiting
Phase
Phase 1
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Transvaginal ultrasound
Serial serum LH, E2, P4
Progesterone 100 Mg Vaginal Insert
Serum P4 day of ET - Control Group
Serum P4 day of ET - Study Group
Embryo transfer
Serum hCG 10 days after ET
Serum P4 10 days after ET
Sponsored by
About this trial
This is an interventional basic science trial for Pregnancy Related focused on measuring implantation rate, infertility, pregnancy rate, natural cycle, luteal phase support, live birth, progesterone
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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….)
Sites / Locations
- ART Fertility Clinics LLC
- ART Fertility Clinics Al Ain
- ART Fertility Clinics Dubai
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Study Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Clinical pregnancy rate
hCG > 15 Iu/ml and ultrasound confirmation of a gestational sac
Live birth rate
Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009)
Serum P4 levels on ET day
Progesterone level on the day of embryo transfer
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
Serum E2 and P4 levels on day 10 after ET procedure
Estradiol and Progesterone levels on day 10 after embryo transfer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05969795
Brief Title
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
Official Title
Comparison of Live Birth Rate (> 24 Weeks) in Natural Cycle (NC) Single Euploid Frozen Embryo Transfers (FET) With Versus Without Luteal Phase Support (LPS)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ART Fertility Clinics LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Infertility, Female
Keywords
implantation rate, infertility, pregnancy rate, natural cycle, luteal phase support, live birth, progesterone
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
342 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Other
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Transvaginal ultrasound
Intervention Description
Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
Intervention Type
Diagnostic Test
Intervention Name(s)
Serial serum LH, E2, P4
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Progesterone 100 Mg Vaginal Insert
Other Intervention Name(s)
Progesterone 100Mg Vag Tab
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum P4 day of ET - Control Group
Intervention Description
Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum P4 day of ET - Study Group
Intervention Description
Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.
Intervention Type
Procedure
Intervention Name(s)
Embryo transfer
Other Intervention Name(s)
ET
Intervention Description
The procedure in which embryo is placed in the uterus.
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum hCG 10 days after ET
Intervention Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum P4 10 days after ET
Intervention Description
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
Primary Outcome Measure Information:
Title
Implantation rate
Description
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).
Time Frame
2 months
Title
Clinical pregnancy rate
Description
hCG > 15 Iu/ml and ultrasound confirmation of a gestational sac
Time Frame
2 months
Title
Live birth rate
Description
Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009)
Time Frame
41 weeks
Title
Serum P4 levels on ET day
Description
Progesterone level on the day of embryo transfer
Time Frame
1 day
Title
Serum E2 and P4 levels on day 5 or 6 after ET procedure
Description
Estradiol and Progesterone levels on day 5 or 6 after embryo transfer
Time Frame
6 days
Title
Serum E2 and P4 levels on day 10 after ET procedure
Description
Estradiol and Progesterone levels on day 10 after embryo transfer
Time Frame
10 days
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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….)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Lawrenz, PhD
Phone
+971 800 337845489
Email
barbara.lawrenz@artfertilityclinics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jonalyn Edades, RN
Phone
+971 800 337845489
Email
jonalyn.edades@artfertilityclinics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Lawrenz, PhD
Organizational Affiliation
ART Fertility Clinics LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
ART Fertility Clinics LLC
City
Abu Dhabi
ZIP/Postal Code
60202
Country
United Arab Emirates
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Lawrenz, PhD
Phone
+971 800 337845489
Email
barbara.lawrenz@artfertilityclinics.com
Facility Name
ART Fertility Clinics Al Ain
City
Al Ain
Country
United Arab Emirates
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastasia Salame
Phone
+971 800 337845489
Email
jonalyn.edades@artfertilityclinics.com
Facility Name
ART Fertility Clinics Dubai
City
Dubai
Country
United Arab Emirates
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Coughlan, PhD
Phone
+971 800 337845489
Email
jonalyn.edades@artfertilityclinics.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
36171152
Citation
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.
Results Reference
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PubMed Identifier
341008
Citation
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.
Results Reference
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PubMed Identifier
6427277
Citation
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.
Results Reference
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PubMed Identifier
30910545
Citation
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.
Results Reference
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PubMed Identifier
36308939
Citation
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.
Results Reference
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PubMed Identifier
36273850
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
34730071
Citation
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.
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Citation
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.
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Citation
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.
Results Reference
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Links:
URL
http://link.springer.com/10.1007/978-3-319-43011-9_63
Description
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
Learn more about this trial
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
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