CClinicalTrials.gg
Status unknownNCT04248309Updated Jan 30, 2020

Serum Progesterone Level in HRT-FET:a RCT

An interventional study of intramuscular progesterone 20-40mg from D3 until pregnancy test in Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown. Open to female participants aged 20 Years to 41 Years. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
423
Allocation
Randomized
Ages
20 Years to 41 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles
03

In context

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 41 Years
Sexes eligible
Female
Accepts 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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
423 participants (estimated)

Study arms

  • 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 )

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

  • 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

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 )

06

What researchers measure

Primary outcomes

  1. Ongoing pregnancy rate

    beyond pregnancy week 12 in HRT-FET cycles

    Time frame: 10 weeks after embryo transfer

Secondary outcomes

  1. Clinical pregnancy rate

    intrauterine gestational sacs by ultrasound

    Time frame: 10 weeks after embryo transfer

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Haiyan L, Gang Y, Yu L, Lin L, Xiaoli C, Qingxue Z. Does serum progesterone level impact the ongoing pregnancy rate in frozen embryo transfer under artificial preparation with vaginal progesterone? Study protocol for a randomized controlled trial. Trials. 2022 Jan 3;23(1):3. doi: 10.1186/s13063-021-05953-8. PubMed 34980220 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04248309
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Responsible party
Haiyan Lin (Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University) — Principal investigator
First posted
Jan 30, 2020
Start date
Mar 2020 (estimated)
Primary completion
Mar 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Jan 30, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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