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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Patients in study group will receive tamoxifen at a daily dose of 40 mg from day 3 to day 8.
Patients in control group will receive estradiol valerate at a dose of 3 mg twice per day from day 3.
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.
Time frame: 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.
Time frame: 1-2years
cycle duration
the total time of endometrium preparation
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1-2 year
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