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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05969795
Other study ID # 2306-ABU-009-BL
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 5, 2023
Est. completion date September 30, 2024

Study information

Verified date November 2023
Source ART Fertility Clinics LLC
Contact Barbara Lawrenz, PhD
Phone +971 800 337845489
Email barbara.lawrenz@artfertilityclinics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 342
Est. completion date September 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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….)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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).
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
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
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.
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)
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

Locations

Country Name City State
United Arab Emirates ART Fertility Clinics LLC Abu Dhabi
United Arab Emirates ART Fertility Clinics Al Ain Al Ain
United Arab Emirates ART Fertility Clinics Dubai Dubai

Sponsors (1)

Lead Sponsor Collaborator
ART Fertility Clinics LLC

Country where clinical trial is conducted

United Arab Emirates, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Clinical pregnancy rate hCG > 15 Iu/ml and ultrasound confirmation of a gestational sac 2 months
Primary 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
Primary Serum P4 levels on ET day Progesterone level on the day of embryo transfer 1 day
Primary 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
Primary Serum E2 and P4 levels on day 10 after ET procedure Estradiol and Progesterone levels on day 10 after embryo transfer 10 days
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