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 (> 24 Weeks) in Natural Cycle Single Euploid Frozen Embryo Transfers With Versus Without Luteal Phase Support
Led by ART Fertility Clinics LLC · Updated on 2025-01-09
342
Participants Needed
3
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether transferring a single genetically normal embryo during a natural menstrual cycle without routine luteal phase support (LPS) is not worse than transferring with LPS. This study focuses on women with regular ovulatory cycles who have at least one genetically tested embryo available, aiming to simplify treatment and improve participant comfort if the outcomes are similar. Participants are randomly assigned to one of two groups. Both groups will have intermittent ultrasounds and blood tests measuring hormone levels to monitor ovulation. In the group without LPS, embryo transfer is scheduled five days after ovulation without additional progesterone support. The group receiving LPS will be given vaginal progesterone starting on the day of embryo transfer and continuing until the pregnancy test, with support extended to seven weeks if pregnancy occurs. Throughout the study, participants will undergo multiple hormone measurements and ultrasounds to track follicular growth and hormone levels before and after embryo transfer. Pregnancy confirmation will occur via blood tests 10 days after transfer. The study will measure implantation rate, clinical pregnancy rate, live birth rate, and hormone levels at specific time points. Participant involvement includes frequent clinic visits for monitoring and blood draws over the course of the treatment cycle and early pregnancy period.
CONDITIONS
Brief 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 18 to 40 years
- Regular ovulatory menstrual cycles
- At least one euploid embryo available after genetic testing 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 conditions affecting implantation such as adenomyosis, Asherman syndrome, endometriosis, uterine fibroids or polyps, isthmocele with fluid, or hydrosalpinx
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Intermittent ultrasound scans and serial blood tests to monitor hormone levels throughout one menstrual cycle
Treatment
Duration - From ovulation until 7 weeks of pregnancy if implantation occurs, or until pregnancy test if no implantation
Participants undergo embryo transfer scheduled on the fifth day after ovulation, with or without luteal phase support using vaginal progesterone depending on group assignment.
1 admission visit for embryo transfer and progesterone blood draw, plus hormone measurements on day 5 or 6 and 10 days after embryo transfer
Follow-up
Duration - Up to 41 weeks to assess live birth outcomes
Participants have blood tests to confirm pregnancy status and monitor hormone levels after embryo transfer.
Blood tests 10 days after embryo transfer and pregnancy monitoring visits as needed
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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M Filicori, J P Butler, W F Crowley
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Erica Ginström Ernstad, Ulla-Britt Wennerholm, Ali Khatibi...
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M R Soules, D K Clifton, R A Steiner...
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https://pubmed.ncbi.nlm.nih.gov/34730071The clinical relevance of luteal phase deficiency: a committee opinion.
Practice Committee of the American Society for Reproductive Medicine
https://pubmed.ncbi.nlm.nih.gov/22819186Increased Preeclampsia Risk and Reduced Aortic Compliance With In Vitro Fertilization Cycles in the Absence of a Corpus Luteum.
Frauke von Versen-Höynck, Amelia M Schaub, Yueh-Yun Chi...
https://pubmed.ncbi.nlm.nih.gov/30636552