Serum Progesterone Level in HRT-FET：a RCT

Sun Yat-sen University

Status: Unknown

Conditions: Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles

Treatments: Drug: intramuscular progesterone 20-40mg from D3 until pregnancy test

Study type: Interventional

Funder types: Other

Identifiers

NCT04248309

2019-HRT-P-05

Details and patient eligibility

About

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.

Enrollment: 423 estimated patients

Sex: Female

Ages: 20 to 41 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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423 participants in 3 patient groups

A1

Experimental group

Description:

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 ）

Treatment:

Drug: intramuscular progesterone 20-40mg from D3 until pregnancy test

A2

No Intervention group

Description:

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

B

No Intervention group

Description:

Group B：serum progesterone ≥7.24ug/L， without additional treatment