EndometriumPhase 4NCT03060304
The Effect of Tamoxifen on Clinical Outcome in Women With Thin Endometrium Undergoing Frozen Thawed Cycle.
A Phase 4 study testing Tamoxifen and estradiol valerate in people with Endometrium, run by Sun Yat-sen University.
Trial summary
Cryopreservation of embryos created during fresh IVF cycles provides a less expensive and time-intensive opportunity for pregnancy. Ideal endometrium thickness is the key point to optimization FET cycle. Researches show that when endometrial thickness is less than 7mm, pregnancy rate dropped significantly. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrium
- What is being tested?
- Tamoxifen and estradiol valerate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Jun 2020
- Phase
- Phase 4
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age ≥20 years and ≤40 years;
- patients that have at least 1 high quality blastocysts;
- patients who are observed endometrial thickness ≤ 7mm in the past natural cycles or hormone replacement cycles repeatedly (twice or even more);
- patients intends to continue to attempt another frozen embryo transfer cycle.
Who cannot join
- patients diagnosed intrauterine adhesions, uterine scarring diverticulum via Hysteroscopy or ultrasonography and have history of uterine cavity operation for the above indication;
- patients have congenital uterine anomalies such as Gemini, the mediastinum in the uterus and so on.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Tamoxifen on Endometrial Thickness and Pregnancy Outcome in Women With Thin Endometrium Undergoing Frozen Thawed Cycle.
Cryopreservation of embryos created during fresh IVF cycles provides a less expensive and time-intensive opportunity for pregnancy. Ideal endometrium thickness is the key point to optimization FET cycle. Researches show that when endometrial thickness is less than 7mm, pregnancy rate dropped significantly. Tamoxifen has been reported to be oestrogenic on the lower genital tract. Several study on intrauterine insemination or ovulation induction suggest that tamoxifen may be a promising alternative for patients with thin endometrium. Based on this ,we want to evaluate the effects of tamoxifen on endometrial thickness and pregnancy outcome in women who failed to develop an adequate endometrial thickness in previous frozen embryo transfer cycle twice or even more times and willing to have another attempt.
Read the detailed description
Objective: To investigate the effects of tamoxifen on endometrial thickness and pregnancy outcome in women with thin endometrium undergoing frozen thawed cycle.
Study design: This is a single center, randomize control clinical trial. We plan to recruit 100 patients from Mar 2017 to Dec 2019, who failed to develop an adequate endometrial thickness in previous frozen embryo transfer cycle twice or even more times and willing to have another attempt, dividing into two group, one prepare the endometrium through ovulation induction with tamoxifen and progesterone(Study Group), the other is hormone replacement cycle (control group).
Intervention: Study Group will give endometrial preparation with tamoxifen and progesterone, control group will prepared with estrogen and progesterone supplementation.
Main outcome measures: The primary outcome of the study was endometrium thickness and clinical pregnancy rate, the secondary outcomes are cycle duration, cycle cancellation rate, implantation rate, miscarriage rate, live birth rate.
- Conditions
- Endometrium
- Being tested
- Tamoxifen, estradiol valerate
- Keywords
- tamoxifen, thin endometrium, frozen embryo transfer, pregnancy rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Also called Tam
Patients in study group will receive tamoxifen at a daily dose of 40 mg from day 3 to day 8.
estradiol valerateDrug
Patients in control group will receive estradiol valerate at a dose of 3 mg twice per day from day 3.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Patients in study group will receive tamoxifen at a daily dose of 40 mg from day 3 to day 8. Follicle diameters are monitored by transvaginal ultrasound and serum levels of E2, P are tested on day 9. If there is a dominant follicle (almost 12 × 12 mm in diameter), endometrial thickness and endometrial pattern, as well as follicular diameters, were monitored daily or every other day till embryo transfer. Serum levels of E2, P are tested on the day before ovulation. If there isn't dominant follicle and intramuscular human menopausal gonadotropin at a dose of 75-150 IU was administered each day after day 12 if there follicle development was poor. The embryo transfer day is decided according embryo development. Receives: Drug: Tamoxifen |
| control group | Active comparator | Patients in control group will receive estradiol valerate at a dose of 3 mg twice per day from day 3. Follicle diameters are monitored by transvaginal ultrasound and serum levels of E2, P are tested on day 9. If endometrial thickness <7mm and E2<100pg/ml, the dose of estradiol valerate can increase or combine other estradiol. Endometrial thickness and endometrial pattern, as well as follicular diameters, were monitored daily or every other day till embryo transfer. Serum levels of E2, P are tested on the day before endometrium transformation. The embryo transfer day is decided according embryo development. Serum levels of E2, P are tested on the day before embryo transfer. Receives: Drug: estradiol valerate |
What is being measured
The primary outcome is the main question the study is designed to answer.
endometrium thickness
Endometrial thickness was defined as the maximal distance between the echogenic interfaces of the endometrium and the myometrium in the plane of the central longitudinal axis of the uterus.
Measured: 1-3 month
clinical pregnancy rate
Clinical pregnancy was considered with the presence of a gestational sac containing yolk sac at transvaginal ultrasonography, including ectopic pregnancy.clinical pregnancy rate is the number of clinical pregnancy patients /the total number of transferred patients in the group.
Measured: 1-2years
Secondary outcomes (5)
cycle duration
the total time of endometrium preparation
Measured: 1-3 month
cycle cancellation rate
cycle cancellation rate is the number of patients that cancell embryo transfer /the total number of patients in the group.
Measured: 1-3 month
implantation rate
Implantation rate was determined by the number of gestational sacs and the total number of embryos transferred at least 4 weeks after embryo transfer.
Measured: 1-2 year
miscarriage rate
miscarriage rate is the number of patients that find pregnancy loss /the total number of transferred patients in the group.
Measured: 1-2 year
live birth rate
live birth rate is the number of patients that delived /the total number of transferred patients in the group.
Measured: 1-2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startMar 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriumStudies of the same condition, open and under way.
- More trials run by 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Xing Yang, M.D. & Ph.D., Study director, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060304
- Sponsor's protocol ID
- newivf20170217
- Status last verified
- Feb 2017
- First submitted
- 18 Feb 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tamoxifen on Endometrial Thickness and Pregnancy Outcome in Women With Thin Endometrium Undergoing Frozen Thawed Cycle.
- ClinicalTrials.gov ID
- NCT03060304
- Acronym / sponsor ID
- newivf20170217
- Conditions
- Endometrium
- Keywords
- tamoxifen, thin endometrium, frozen embryo transfer, pregnancy rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 23 Feb 2017 (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.
Cryopreservation of embryos created during fresh IVF cycles provides a less expensive and time-intensive opportunity for pregnancy. Ideal endometrium thickness is the key point to optimization FET cycle. Researches show that when endometrial thickness is less than 7mm, pregnancy rate dropped significantly. Tamoxifen has been reported to be oestrogenic on the lower genital tract. Several study on intrauterine insemination or ovulation induction suggest that tamoxifen may be a promising alternative for patients with thin endometrium. Based on this ,we want to evaluate the effects of tamoxifen on endometrial thickness and pregnancy outcome in women who failed to develop an adequate endometrial thickness in previous frozen embryo transfer cycle twice or even more times and willing to have another attempt.
Detailed description
Objective: To investigate the effects of tamoxifen on endometrial thickness and pregnancy outcome in women with thin endometrium undergoing frozen thawed cycle.
Study design: This is a single center, randomize control clinical trial. We plan to recruit 100 patients from Mar 2017 to Dec 2019, who failed to develop an adequate endometrial thickness in previous frozen embryo transfer cycle twice or even more times and willing to have another attempt, dividing into two group, one prepare the endometrium through ovulation induction with tamoxifen and progesterone(Study Group), the other is hormone replacement cycle (control group).
Intervention: Study Group will give endometrial preparation with tamoxifen and progesterone, control group will prepared with estrogen and progesterone supplementation.
Main outcome measures: The primary outcome of the study was endometrium thickness and clinical pregnancy rate, the secondary outcomes are cycle duration, cycle cancellation rate, implantation rate, miscarriage rate, live birth rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: TamoxifenPatients in study group will receive tamoxifen at a daily dose of 40 mg from day 3 to day 8. Follicle diameters are monitored by transvaginal ultrasound and serum levels of E2, P are tested on day 9. If there is a dominant follicle (almost 12 × 12 mm in diameter), endometrial thickness and endometrial pattern, as well as follicular diameters, were monitored daily or every other day till embryo transfer. Serum levels of E2, P are tested on the day before ovulation. If there isn't dominant follicle and intramuscular human menopausal gonadotropin at a dose of 75-150 IU was administered each day after day 12 if there follicle development was poor. The embryo transfer day is decided according embryo development. |
| control group | Active comparator | Drug: estradiol valeratePatients in control group will receive estradiol valerate at a dose of 3 mg twice per day from day 3. Follicle diameters are monitored by transvaginal ultrasound and serum levels of E2, P are tested on day 9. If endometrial thickness <7mm and E2<100pg/ml, the dose of estradiol valerate can increase or combine other estradiol. Endometrial thickness and endometrial pattern, as well as follicular diameters, were monitored daily or every other day till embryo transfer. Serum levels of E2, P are tested on the day before endometrium transformation. The embryo transfer day is decided according embryo development. Serum levels of E2, P are tested on the day before embryo transfer. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women age ≥20 years and ≤40 years;
- patients that have at least 1 high quality blastocysts;
- patients who are observed endometrial thickness ≤ 7mm in the past natural cycles or hormone replacement cycles repeatedly (twice or even more);
- patients intends to continue to attempt another frozen embryo transfer cycle.
Key exclusion criteria (2 listed)
- patients diagnosed intrauterine adhesions, uterine scarring diverticulum via Hysteroscopy or ultrasonography and have history of uterine cavity operation for the above indication;
- patients have congenital uterine anomalies such as Gemini, the mediastinum in the uterus and so on.
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 |
|---|---|---|
| TamoxifenAlso: TamPatients in study group will receive tamoxifen at a daily dose of 40 mg from day 3 to day 8. | Drug | study group |
| estradiol valeratePatients in control group will receive estradiol valerate at a dose of 3 mg twice per day from day 3. | Drug | control group |
Primary outcome
endometrium thickness
Time frame: 1-3 month
Endometrial thickness was defined as the maximal distance between the echogenic interfaces of the endometrium and the myometrium in the plane of the central longitudinal axis of the uterus.
clinical pregnancy rate
Time frame: 1-2years
Clinical pregnancy was considered with the presence of a gestational sac containing yolk sac at transvaginal ultrasonography, including ectopic pregnancy.clinical pregnancy rate is the number of clinical pregnancy patients /the total number of transferred patients in the group.
5 secondary outcomes
cycle duration
Time frame: 1-3 month
cycle cancellation rate
Time frame: 1-3 month
implantation rate
Time frame: 1-2 year
miscarriage rate
Time frame: 1-2 year
live birth rate
Time frame: 1-2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
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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.
Xing Yang, M.D. & Ph.D. study director
Sixth Affiliated Hospital, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamoxifen and estradiol valerate in people with Endometrium, run by 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 4 inclusion and 2 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 24 Feb 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xing Yang, M.D. & Ph.D. (020-38048013, yxing_8358@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometrium thickness (time frame: 1-3 month). The study lists 2 primary outcomes in all. 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 24 Feb 2017.