Thin Endometrium Undergoing Frozen-thawed Embryo Transfer

NCT04292886 | Unknown DMC

• 1 other identifier: NanjingU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thin Endometrium

Keywords

thin endometrium

Outcome Measures

Primary Outcomes (1)

• Endometrial thickness

  Endometrial thickness were record using transvaginal ultrasound scan.

  within the 15 days (plus or minus 5 days) after oral drugs

Study Arms (2)

thin endometrium ,treatment,Tamoxifen

ACTIVE COMPARATOR

From the 2nd day of the menstrual cycle, the patient took tamoxifen and femoston

Drug: Tamoxifen and femoston

thin endometrium ,treatment,Vitamin C

PLACEBO COMPARATOR

From the 2nd day of the menstrual cycle, the patient took Vitamin C and femoston

Drug: Vitamin C and femoston

Interventions

Tamoxifen and femoston DRUG

oral

thin endometrium ,treatment,Tamoxifen

Vitamin C and femoston DRUG

Vitamin C and femoston

thin endometrium ,treatment,Vitamin C

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nanjing University: lead

Study Sites (1)

Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Interventions

Tamoxifen; femoston; Ascorbic Acid

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Haixiang Sun, Ph.D

  Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qingqing Shi, Ph.D

CONTACT

15996312878; qqshnju@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Qingqing Shi

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 3, 2020
• Study Start: October 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: November 30, 2021
• Last Updated: March 3, 2020

Record last verified: 2020-03

Locations

CN (1)