Association between programmed frozen embryo transfer and hypertensive disorders of pregnancy.
Pietro Bortoletto, Malavika Prabhu, Valerie L Baker
https://pubmed.ncbi.nlm.nih.gov/36171152Actively Recruiting
Phase 1
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
ID05969795
Comparison of Live Birth Rate in Natural Cycle Single Euploid Frozen Embryo Transfers With and Without Hormone Support
Led by ART Fertility Clinics LLC · Updated on 2025-01-09
342
Participants Needed
3
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether transferring a single euploid embryo in a natural cycle without routine luteal phase support (LPS) is as effective as transfers with LPS. The study focuses on women aged 18 to 40 years with regular ovulatory cycles who have at least one tested euploid embryo. If the study shows no difference in live birth rates, it could simplify treatment and improve patient comfort. Participants will undergo monitoring with intermittent transvaginal ultrasounds to track follicle growth and serial blood tests measuring luteinizing hormone (LH), estradiol (E2), and progesterone (P4) to confirm ovulation. The group receiving LPS will be given vaginal progesterone starting on the day of embryo transfer (ET), with dosing adjusted up to 300 mg daily until pregnancy testing. The study compares outcomes between those who receive vaginal progesterone and those who do not. Throughout the study, participants will have blood tests to measure hormone levels on the day of ET and several days afterward. Pregnancy confirmation is done by measuring serum hCG 10 days post-ET. Key outcomes assessed include implantation rate and clinical pregnancy rate at 2 months, as well as live birth rate after 41 weeks. Hormone levels will be closely monitored to understand their relationship to pregnancy success.
CONDITIONS
Official Title
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
Who Can Participate
Age: 18Years - 40Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 18 and 40 years
- Regular ovulatory cycles
- At least one euploid embryo available after Trophectoderm biopsy for PGT-A on day 5 or 6
- Ovulation detected by progesterone rise above 1.0 ng/ml after LH surge
- Progesterone level of at least 5 ng/ml on day 4 after ovulation
You will not qualify if you...
- History of repeated pre-menstrual spotting
- Uterine or ovarian anatomical changes affecting implantation, such as adenomyosis, Asherman syndrome, endometriosis, uterine fibroids or polyps, isthmocele with intracavitary fluid, or hydrosalpinx
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 3 locations
1
ART Fertility Clinics LLC
Abu Dhabi, United Arab Emirates, 60202
Actively Recruiting
2
ART Fertility Clinics Al Ain
Al Ain City, United Arab Emirates
Actively Recruiting
3
ART Fertility Clinics Dubai
Dubai, United Arab Emirates
Not Yet Recruiting
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Research Team
B
Barbara Lawrenz, PhD
J
Jonalyn Edades, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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