Infertility, Fertility Issues, Infertility, Female
Conditions
Keywords
Implantation, Infertility, Blastocyst, HRT, Progesterone
Brief summary
The goal of this study is to compare the difference in clinical pregnancy, miscarriage and livebirth rate between day 6 euploid blastocyst transfer on the 6th and the 7th day of progesterone exposure in Hormonal Replacement Therapy (HRT) FET cycles. This prospective & randomized study will only include euploid day 6 blastocysts. This will be the first prospective study of euploid day 6 blastocysts thereby excluding aneuploidy as a cause of miscarriage and implantation failure. The point of randomization will occur on the day of progesterone commencement.
Detailed description
Traditionally the duration of progesterone exposure before embryo transfer has been considered equal for day 5 and day 6 embryos but this may not be the case and warrants further study. The optimal preparation of the endometrium in frozen embryo transfer (FET) cycles is yet to be determined. Synchronization between the embryonic stage and the endometrial window of implantation (WOI) is crucial and progesterone plays a critical role in the WOI (1). Data on the optimal route of administration, the dose and duration of progesterone supplementation before blastocyst transfer are inconsistent (2,3). In view of the current lack of evidence, this study will be of importance.
Interventions
DIAGNOSTIC_TESTTransvaginal ultrasound
Transvaginal ultrasound throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of an ovarian dominant follicle
DIAGNOSTIC_TESTSerum LH, E2, P4
In conjunction with ultrasound monitoring, participants will undergo serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4) levels
Participants will commence estradiol valerate 4 mg ( 2 x 2 mg) on day 2 / day 3 of menses. Estradiol will be increased to 6 mg on day 2 of estrogen treatment, and continued at a daily dose of 6 mg (3 tablets daily)
The initial progesterone dose of 100 mg will be commenced at 13hrs and repeated at 21hrs considered day 1 (vaginal suppository) when an optimal endometrial thickness for each participant has been achieved with a trilaminar appearance. The following day (day 2) progesterone administration will be increased to 100 mg vaginally three times daily
DIAGNOSTIC_TESTSerum P4 day of ET
On the day of embryo transfer (ET), a blood test is taken to measure serum P4
PROCEDUREEmbryo transfer
Procedure in which embryo is transferred into the uterus
Sponsors
ART Fertility Clinics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18 years to 43 years. * Having at least 1 euploid cryopreserved day 6 blastocyst of at least Grade BB quality. * Endometrial trilaminar appearance on the day of progesterone start
Exclusion criteria
* Uterine abnormality * Hydrosalpinx * Asherman syndrome * Any known contraindications or allergy to oral estradiol or progesterone. * Intention to treat : exclusion factors : 1. Spontaneous ovulation HRT cycle 2. Discontinuation of HRT medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Livebirth rate (LBR) | 41 weeks | Defined as the delivery of a live infant born after 24 completed weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy rate | 5 weeks | Positive hCG, but at 5 gestational weeks no ultrasonographic visible gestational sac seen but without a further development into a clinical pregnancy) |
| Clinical pregnancy rate | 5 weeks | Ultrasonographic sac visible at 5 gestational weeks |
| Ongoing pregnancy rate after 12 weeks | 13 weeks | Viable pregnancy with a gestational age of more than 12 weeks |
| Miscarriage rate | 24 weeks | Spontaneous loss of a clinical pregnancy before 24 completed weeks of gestation |
Countries
United Arab Emirates
Contacts
Primary ContactBarbara Lawrenz, PhD
Backup ContactJonalyn Edades, RN
Outcome results
None listed