Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
Comparison of Live Birth Rate (> 24 Weeks) in Natural Cycle (NC) Single Euploid Frozen Embryo Transfers (FET) With Versus Without Luteal Phase Support (LPS)
ART Fertility Clinics LLC
342 participants
Sep 5, 2023
INTERVENTIONAL
Conditions
Summary
To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.
Eligibility
Inclusion Criteria5
- 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 Criteria2
- 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….)
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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
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT05969795