Hormone Replacement TherapyNCT04503915
Estrogen Supplementation Mode in HRT-FET Cycle: a RCT
A study testing different estrogen supplementation modes in people with Hormone Replacement Therapy and Estrogen, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
A systematic review and meta-analysis concluded that there is insufficient evidence to recommend one particular protocol for HRT with regard to pregnancy rates after frozen embryo transfer, and no comparison of estrogen dose or route of administration was included in the review[7]. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Hormone Replacement Therapy, Estrogen, Live Birth Rate
- What is being tested?
- different estrogen supplementation modes
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 784 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Dec 2023
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged <42 years at the time of HRT-FET
- Replacing 1-2 early cleavage embryos or blastocysts after thawing.
Who cannot join
- Preimplantation genetic testing(PGT)
- Use of donor oocytes
- Hydrosalpinx shown on pelvic scanning and not surgically treated such as tubal ligation or resection
- Severe uterine adhesion
- The endometrial thickness cannot reach 8mm in previous fresh cycles or HRT -FET cycles
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Randomized Controlled Trial Comparing a Step-wise Increase Versus a Constant Dose of Estrogen Supplementation in Frozen-thawed Embryo Transfer Cycles Using Hormone Replacement
A systematic review and meta-analysis concluded that there is insufficient evidence to recommend one particular protocol for HRT with regard to pregnancy rates after frozen embryo transfer, and no comparison of estrogen dose or route of administration was included in the review[7]. It is worth highlighting that the authors did not find any literature discussing the effect of estrogen dose and route of administration for HRT on reproductive outcomes. In 2016, a retrospective cohort study concluded that there is no difference in live birth rates between a constant dose versus an increasing dose of estrogen in oocyte donation cycles with oral or transdermal supplementation[6]. In order to provide good evidence about pattern of estrogen supplementation in HRT-FET, a randomized controlled study is urgently needed.
The present randomized controlled study aims to compare between a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol on the live birth rate of HRT-FET cycles.
Read the detailed description
The objective is to compare between a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol on live birth rate of HRT-FET cycles.
This is a multicenter randomized controlled trial. Women undergoing HRT-FET will be recruited and randomized to use a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol.
Participation in the study is totally voluntary. The subjects can withdraw from the study at any time and they will still receive standard medical care.
Women being scheduled for HRT-FET will be assessed for eligibility. Eligible women will be recruited in the study and each woman will only be included in the study once.
Informed written consent will be obtained prior to recruitment. The baseline characteristics will be collected. Transvaginal ultrasound will be done to measure the endometrial thickness on the day of progesterone supplementation. Embryo transfer will be performed 3 days or 5 days after progesterone use, depending on replacement of cleaving stage embryos or blastocysts respectively.
- Conditions
- Hormone Replacement Therapy, Estrogen, Live Birth Rate
- Being tested
- different estrogen supplementation modes
- Keywords
- estrogen supplementation, HRT, Live birth rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different estrogen supplementation modesProcedure or surgery
The different estrogen supplementation modes are randomized into two groups.
| Study group | Role | What they receive |
|---|---|---|
| Constant group | Experimental | Women will receive oral estradiol valerate (Progynova®; Bayer Schering Pharma AG, Berlin, Germany) 3 mg bid for 14 days for endometrial priming from the second or third day of the menstrual cycle. Receives: Procedure: different estrogen supplementation modes |
| Step -up group | Active comparator | Women will receive estradiol valerate 2mg once daily for 4 days from the second to fifth day,followed by 2mg bid for 4 days from the sixth to ninth day and then 3mg bid for 6 days from tenth to fifteenth day of menstrual cycle. Receives: Procedure: different estrogen supplementation modes |
What is being measured
The primary outcome is the main question the study is designed to answer.
live-birth rate per ET
Live birth was defined as the delivery of at least one live born baby beyond 28 weeks of gestation.
Measured: Up to 12 months
Secondary outcomes (1)
clinical pregnancy rate
- clinical pregnancy: presence of intrauterine gestational sac on pelvic ultrasound at 6 weeks of gestation
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Replacement TherapyStudies 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
- None (open label)
- Enrolment
- 784 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
- Investigators
- Yi Zhang, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503915
- Sponsor's protocol ID
- HRT-E2
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Until the completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial Comparing a Step-wise Increase Versus a Constant Dose of Estrogen Supplementation in Frozen-thawed Embryo Transfer Cycles Using Hormone Replacement
- ClinicalTrials.gov ID
- NCT04503915
- Acronym / sponsor ID
- HRT-E2
- Conditions
- Hormone Replacement Therapy, Estrogen, Live Birth Rate
- Keywords
- estrogen supplementation, HRT, Live birth rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 784 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 7 Aug 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.
A systematic review and meta-analysis concluded that there is insufficient evidence to recommend one particular protocol for HRT with regard to pregnancy rates after frozen embryo transfer, and no comparison of estrogen dose or route of administration was included in the review[7]. It is worth highlighting that the authors did not find any literature discussing the effect of estrogen dose and route of administration for HRT on reproductive outcomes. In 2016, a retrospective cohort study concluded that there is no difference in live birth rates between a constant dose versus an increasing dose of estrogen in oocyte donation cycles with oral or transdermal supplementation[6]. In order to provide good evidence about pattern of estrogen supplementation in HRT-FET, a randomized controlled study is urgently needed.
The present randomized controlled study aims to compare between a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol on the live birth rate of HRT-FET cycles.
Detailed description
The objective is to compare between a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol on live birth rate of HRT-FET cycles.
This is a multicenter randomized controlled trial. Women undergoing HRT-FET will be recruited and randomized to use a constant estrogen dose protocol and a step-wise increasing estrogen dose protocol.
Participation in the study is totally voluntary. The subjects can withdraw from the study at any time and they will still receive standard medical care.
Women being scheduled for HRT-FET will be assessed for eligibility. Eligible women will be recruited in the study and each woman will only be included in the study once.
Informed written consent will be obtained prior to recruitment. The baseline characteristics will be collected. Transvaginal ultrasound will be done to measure the endometrial thickness on the day of progesterone supplementation. Embryo transfer will be performed 3 days or 5 days after progesterone use, depending on replacement of cleaving stage embryos or blastocysts respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constant group | Experimental | Procedure: different estrogen supplementation modesWomen will receive oral estradiol valerate (Progynova®; Bayer Schering Pharma AG, Berlin, Germany) 3 mg bid for 14 days for endometrial priming from the second or third day of the menstrual cycle. |
| Step -up group | Active comparator | Procedure: different estrogen supplementation modesWomen will receive estradiol valerate 2mg once daily for 4 days from the second to fifth day,followed by 2mg bid for 4 days from the sixth to ninth day and then 3mg bid for 6 days from tenth to fifteenth day of menstrual cycle. |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged <42 years at the time of HRT-FET
- Replacing 1-2 early cleavage embryos or blastocysts after thawing.
Key exclusion criteria (5 listed)
- Preimplantation genetic testing(PGT)
- Use of donor oocytes
- Hydrosalpinx shown on pelvic scanning and not surgically treated such as tubal ligation or resection
- Severe uterine adhesion
- The endometrial thickness cannot reach 8mm in previous fresh cycles or HRT -FET cycles
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 |
|---|---|---|
| different estrogen supplementation modesThe different estrogen supplementation modes are randomized into two groups. | Procedure or surgery | Constant group, Step -up group |
Primary outcome
live-birth rate per ET
Time frame: Up to 12 months
Live birth was defined as the delivery of at least one live born baby beyond 28 weeks of gestation.
1 secondary outcome
clinical pregnancy rate
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: No. Until the completion of the study.
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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.
Yi Zhang study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A study testing different estrogen supplementation modes in people with Hormone Replacement Therapy and Estrogen, 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 2 inclusion and 5 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 7 Aug 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?
Contact Haiyan Lin (15913154456, 709235159@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live-birth rate per ET (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2020.