Serum Progesterone Level in HRT-FET：a RCT

Not Applicable

• Conditions: Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles
• Interventions: Drug: intramuscular progesterone 20-40mg from D3 until pregnancy test

• Registration Number: NCT04248309
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-28
• Study First Posted: 2020-01-30
• Last Update Posted: 2020-01-30
• Study Start: 2020-03
• Primary Completion: 2021-03
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 423

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A1	intramuscular progesterone 20-40mg from D3 until pregnancy test	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 ）

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	10 weeks after embryo transfer	beyond pregnancy week 12 in HRT-FET cycles

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	10 weeks after embryo transfer	intrauterine gestational sacs by ultrasound