Endometrium
Conditions
Keywords
tamoxifen, thin endometrium, frozen embryo transfer, pregnancy rate
Brief 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. 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.
Interventions
DRUGTamoxifen
Patients in study group will receive tamoxifen at a daily dose of 40 mg from day 3 to day 8.
DRUGestradiol valerate
Patients in control group will receive estradiol valerate at a dose of 3 mg twice per day from day 3.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open Label
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women age ≥20 years and ≤40 years; 2. patients that have at least 1 high quality blastocysts; 3. patients who are observed endometrial thickness ≤ 7mm in the past natural cycles or hormone replacement cycles repeatedly (twice or even more); 4. patients intends to continue to attempt another frozen embryo transfer cycle.
Exclusion criteria
1. patients diagnosed intrauterine adhesions, uterine scarring diverticulum via Hysteroscopy or ultrasonography and have history of uterine cavity operation for the above indication; 2. patients have congenital uterine anomalies such as Gemini, the mediastinum in the uterus and so on.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| endometrium thickness | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| implantation rate | 1-2 year | Implantation rate was determined by the number of gestational sacs and the total number of embryos transferred at least 4 weeks after embryo transfer. |
| cycle duration | 1-3 month | the total time of endometrium preparation |
| live birth rate | 1-2 year | live birth rate is the number of patients that delived /the total number of transferred patients in the group. |
| miscarriage rate | 1-2 year | miscarriage rate is the number of patients that find pregnancy loss /the total number of transferred patients in the group. |
| cycle cancellation rate | 1-3 month | cycle cancellation rate is the number of patients that cancell embryo transfer /the total number of patients in the group. |
Contacts
Primary ContactXing Yang, M.D. & Ph.D.
Outcome results
None listed