Serum Progesterone Level in HRT-FET:a RCT

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 2021

Interventions

  • Drug: intramuscular 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 )

Arms, Groups and Cohorts

  • Experimental: A1
    • 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 )
  • No Intervention: A2
    • 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
    • Group B:serum progesterone ≥7.24ug/L, without additional treatment

Clinical Trial Outcome Measures

Primary Measures

  • Ongoing pregnancy rate
    • Time Frame: 10 weeks after embryo transfer
    • beyond pregnancy week 12 in HRT-FET cycles

Secondary Measures

  • Clinical pregnancy rate
    • Time Frame: 10 weeks after embryo transfer
    • intrauterine gestational sacs by ultrasound

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 41 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Haiyan Lin, Principal investigator – Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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