Thin Endometrium Undergoing Frozen-thawed Embryo Transfer

Study Overview
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Brief Summary
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The endometrium is essential for embryo implantation. The clinical pregnancy rate and live birth rate of patients with thin endometrium are significantly lower than those of normal endometrium. Previous studies have shown that tamoxifen has advantages for improving endometrial thickness. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy between hormone replacement and Tamoxifen combined Of hormone replacement.This is a prospective, randomized placebo-controlled, double-blind clinical trial that includes 120 patients younger than 38 years old with a thin endometrium preparing for frozen embryo transfer. Participants will be randomly assigned (1: 1) into two parallel groups: estrogen replacement and tamoxifen combined with estrogen replacement.Frozen embryo resuscitation transfer cycle for thin endometrium patients。This is the first randomized controlled trial to comparing estrogen and estrogen combined with tamoxifen for endometrial improvement，The results of this study will provide evidence for the efficacy of the strategy of frozen embryo transfer cycle for thin endometrium patients.

Official Title
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Hormone Replacement Versus Tamoxifen Combined Of Hormone Replacement in Women With a Thin Endometrium Undergoing Frozen-thawed Embryo Transfer

Conditions
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Thin Endometrium

Intervention / Treatment
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* Drug: Tamoxifen and femoston
* Drug: Vitamin C and femoston


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Younger than 38 years old, basal serum level of follicle stimulating hormone <10 IU / L; (2) Endometrium is less than 8mm in at least 2 cycles: superovulation cycle / natural cycle / estrogen replacement therapy / ovarian stimulation cycle; (3) at least 1 high quality frozen embryo; (4) There are no comorbidities that clearly affect pregnancy, such as adenomyosis, endometriosis, and intrauterine adhesions; Exclusion Criteria: abnormal karyotype; Accompanying other diseases of the uterus: uterine muscular wall myomas that affect the uterine cavity shape, more severe adenomyosis, severe endometriosis, congenital uterine malformations, endometrial tuberculosis, etc .; Contraindications to hormone replacement therapy; Participating in other clinical research; History of previous fundus diseases;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: thin endometrium ,treatment,Tamoxifen<br>From the 2nd day of the menstrual cycle, the patient took tamoxifen and femoston | Drug: Tamoxifen and femoston<br>* oral<br>|
| Placebo Comparator: thin endometrium ,treatment,Vitamin C<br>From the 2nd day of the menstrual cycle, the patient took Vitamin C and femoston | Drug: Vitamin C and femoston<br>* Vitamin C and femoston<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endometrial thickness | Endometrial thickness were record using transvaginal ultrasound scan. | within the 15 days (plus or minus 5 days) after oral drugs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thin endometrium