Serum Progesterone Level in HRT-FET：a RCT

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Serum Progesterone Level on Day 3 in HRT-FET Cycles on the Clnical Outcome: a Randomized Controlled Study

Conditions
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Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles

Intervention / Treatment
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* Drug: intramuscular progesterone 20-40mg from D3 until pregnancy test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HRT-FET cycles，including GnRHa-HRT-FET Age<41 years old BMI<30kg/m2 TSH and PRL normal 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: history of Moderate and Severe uterine adhesion； presence of hydrosapinx diameter >2cm Endometrosis at stage III-IV Recurrent implantation failure (>3 times of embryo transfer cycle)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br>The included patient should test serum progesterone level on D3 no matter which day perform the embryo transfer. According to the progesterone level, there are two groups, Group A: serum progesterone <7.24ug/L, followed by randomized A1: plus additional treatment（intramuscular progesterone 20-40mg from D3 ） | Drug: intramuscular progesterone 20-40mg from D3 until pregnancy test<br>* serum progesterone <7.24ug/L, followed by randomized A1: plus additional treatment（intramuscular progesterone 20-40mg from D3 ）<br>|
| No Intervention: A2<br>The included patient should test serum progesterone level on D3 no matter which day perform the embryo transfer. According to the progesterone level, there are two groups, Group A: serum progesterone <7.24ug/L, followed by randomized A2：without additional treatment | |
| No Intervention: B<br>Group B：serum progesterone ≥7.24ug/L， without additional treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | beyond pregnancy week 12 in HRT-FET cycles | 10 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | intrauterine gestational sacs by ultrasound | 10 weeks after embryo transfer |