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Thin Endometrium Undergoing Frozen-thawed Embryo Transfer

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ClinicalTrials.gov Identifier: NCT04292886
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Li-jun Ding, Nanjing University

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.

Condition or disease Intervention/treatment Phase
Thin Endometrium Drug: Tamoxifen and femoston Drug: Vitamin C and femoston Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Hormone Replacement Versus Tamoxifen Combined Of Hormone Replacement in Women With a Thin Endometrium Undergoing Frozen-thawed Embryo Transfer
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

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




Primary Outcome Measures :
  1. Endometrial thickness [ Time Frame: within the 15 days (plus or minus 5 days) after oral drugs ]
    Endometrial thickness were record using transvaginal ultrasound scan.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292886


Contacts
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Contact: Qingqing Shi, Ph.D 15996312878 qqshnju@sina.com

Locations
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China, Jiangsu
Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Qingqing Shi, Ph.D       qqshnju@sina.com   
Sponsors and Collaborators
Nanjing University
Investigators
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Principal Investigator: Haixiang Sun, Ph.D Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
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Responsible Party: Li-jun Ding, Qingqing Shi, Nanjing University
ClinicalTrials.gov Identifier: NCT04292886    
Other Study ID Numbers: NanjingU
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020

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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
Keywords provided by Li-jun Ding, Nanjing University:
thin endometrium
Additional relevant MeSH terms:
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Tamoxifen
Ascorbic Acid
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents