Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Diagnostic Test: Transvaginal ultrasound
Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
Diagnostic Test: 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).
Diagnostic Test: 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.
Procedure: Embryo transfer
The procedure in which embryo is placed in the uterus.
Other Names:
Diagnostic Test: 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)
Diagnostic Test: 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: 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. |
Diagnostic Test: Transvaginal ultrasound
Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth
Diagnostic Test: 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).
Drug: 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
Other Names:
Diagnostic Test: 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
Procedure: Embryo transfer
The procedure in which embryo is placed in the uterus.
Other Names:
Diagnostic Test: 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)
Diagnostic Test: 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
|
Outcome Measures
Primary Outcome Measures
- Implantation rate [2 months]
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 [2 months]
hCG > 15 Iu/ml and ultrasound confirmation of a gestational sac
- Live birth rate [41 weeks]
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 [1 day]
Progesterone level on the day of embryo transfer
- Serum E2 and P4 levels on day 5 or 6 after ET procedure [6 days]
Estradiol and Progesterone levels on day 5 or 6 after embryo transfer
- Serum E2 and P4 levels on day 10 after ET procedure [10 days]
Estradiol and Progesterone levels on day 10 after embryo transfer
Eligibility Criteria
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….)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ART Fertility Clinics LLC | Abu Dhabi | United Arab Emirates | 60202 | |
| 2 | ART Fertility Clinics Al Ain | Al Ain | United Arab Emirates | ||
| 3 | ART Fertility Clinics Dubai | Dubai | United Arab Emirates |
Sponsors and Collaborators
- ART Fertility Clinics LLC
Investigators
- Principal Investigator: Barbara Lawrenz, PhD, ART Fertility Clinics LLC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- 2306-ABU-009-BL