Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles
Conditions
Brief summary
In the window of implantation, progesterone plays an important role. Sufficient serum progesterone is basic for ongoing pregnancy. Vaginal progesterone is more and more widely used in ART. As it has no hepatic first pass effect. What is the optimal serum level for pregnancy when use vaginal progesterone is not known yet? Hormone replacement therapy- FET is the optimal strategy to explore this question. There are some retrospective studies showed that the serum progesterone level on embryo transfer day (D3 or D5) or pregnancy test day (D14) lower than 10-11ng/ml is significantly associated with ongoing pregnancy rate in HRT-FET cycles. This prospective study is designed to compare the ongoing pregnancy rate between different serum progesterone levels on D3 and to explore the intervention of additional progesterone supplement since D3 is helpful in HRT-FET cycles.
Interventions
DRUGintramuscular progesterone 20-40mg from D3 until pregnancy test
serum progesterone \<7.24ug/L, followed by randomized A1: plus additional treatment（intramuscular progesterone 20-40mg from D3 ）
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 41 Years
Healthy volunteers
No
Inclusion criteria
1. HRT-FET cycles，including GnRHa-HRT-FET 2. Age\<41 years old 3. BMI\<30kg/m2 4. TSH and PRL normal 5. Endometrium thickness ≥8mm on D0 6） embryo transfer completed with at least 1 top-quality embryo (7-9 cell Grade 1 or D5 beyond grade 3 ) 7） Scandalized luteal phase support： transvaginal progesterone 0.2 tid with or without oral progesterone 10mg bid 8） included once for every patient
Exclusion criteria
1. history of Moderate and Severe uterine adhesion； 2. presence of hydrosapinx diameter \>2cm 3. Endometrosis at stage III-IV 4. Recurrent implantation failure (\>3 times of embryo transfer cycle)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 10 weeks after embryo transfer | beyond pregnancy week 12 in HRT-FET cycles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 10 weeks after embryo transfer | intrauterine gestational sacs by ultrasound |
Outcome results
None listed