Thin Endometrium Undergoing Frozen-thawed Embryo Transfer

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

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.

Study Overview

• Status: Unknown
• Conditions: Thin Endometrium
• Intervention / Treatment: Drug: Tamoxifen and femoston; Drug: Vitamin C and femoston

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
      • Contact: Qingqing Shi, Ph.D; Email: qqshnju@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

1. abnormal karyotype;
2. 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 .;
3. Contraindications to hormone replacement therapy;
4. Participating in other clinical research;
5. History of previous fundus diseases;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanjing University
• Investigators: Principal Investigator: Haixiang Sun, Ph.D, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: March 1, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 3, 2020
• Last Update Submitted That Met QC Criteria: March 2, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: thin endometrium
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Micronutrients; Hormone Antagonists; Vitamins; Bone Density Conservation Agents; Estrogen Antagonists; Antioxidants; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Tamoxifen; Ascorbic Acid
• Other Study ID Numbers: NanjingU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No