Progesterone,Hormone Replacement Thawed Embryo Transfer CyclesNCT04248309
Serum Progesterone Level in HRT-FET：a RCT
A study testing intramuscular progesterone 20-40mg from D3 until pregnancy test in people with Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 41 years, women only
- Conditions the study is for
- Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles
- What is being tested?
- intramuscular progesterone 20-40mg from D3 until pregnancy test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 423 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
Official title: The Effect of Serum Progesterone Level on Day 3 in HRT-FET Cycles on the Clnical Outcome: a Randomized Controlled Study
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.
- Being tested
- intramuscular progesterone 20-40mg from D3 until pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramuscular progesterone 20-40mg from D3 until pregnancy testDrug
serum progesterone <7.24ug/L, followed by randomized A1: plus additional treatment（intramuscular progesterone 20-40mg from D3 ）
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | 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 ） Receives: Drug: intramuscular progesterone 20-40mg from D3 until pregnancy test |
| A2 | No intervention | 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 B：serum progesterone ≥7.24ug/L， without additional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
beyond pregnancy week 12 in HRT-FET cycles
Measured: 10 weeks after embryo transfer
Secondary outcomes (1)
Clinical pregnancy rate
intrauterine gestational sacs by ultrasound
Measured: 10 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Progesterone,Hormone Replacement Thawed Embryo Transfer CyclesStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 423 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiyan Lin, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248309
- Sponsor's protocol ID
- 2019-HRT-P-05
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Serum Progesterone Level on Day 3 in HRT-FET Cycles on the Clnical Outcome: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04248309
- Acronym / sponsor ID
- 2019-HRT-P-05
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 423 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: intramuscular progesterone 20-40mg from D3 until pregnancy testThe 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 ） |
| A2 | No intervention | –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 B：serum progesterone ≥7.24ug/L， without additional treatment |
Who may qualify
- Ages
- 20 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intramuscular progesterone 20-40mg from D3 until pregnancy testserum progesterone <7.24ug/L, followed by randomized A1: plus additional treatment（intramuscular progesterone 20-40mg from D3 ） | Drug | A1 |
Primary outcome
Ongoing pregnancy rate
Time frame: 10 weeks after embryo transfer
beyond pregnancy week 12 in HRT-FET cycles
1 secondary outcome
Clinical pregnancy rate
Time frame: 10 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Derived from this study: PubMed 34980220Haiyan 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.
- Individual participant dataSharing planned: Undecided
Related trials for Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles
Not yet recruitingObservational study
Association Between Serum Progesterone Levels on Embryo Transfer Day and Clinical Pregnancy in Frozen-thawed Embryo Transfer Cycles Using Hormone Replacement Therapy
Infertility Assisted Reproductive Technology
RecruitingObservational study
Impact of Serum Progesterone Levels on Embryo Transfer Day on Clinical Pregnancy
Reproductive Issues
RecruitingPhase 3
Progesterone-modified Natural Cycle for FET
Infertility, Female
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing intramuscular progesterone 20-40mg from D3 until pregnancy test in people with Progesterone,Hormone Replacement Thawed Embryo Transfer Cycles, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 10 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04248309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.