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Clinical Study of in Situ Regeneration of Endometrium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04233892
Recruitment Status : Enrolling by invitation
First Posted : January 18, 2020
Last Update Posted : September 1, 2021
Sponsor:
Collaborator:
Chinese Academy of Sciences
Information provided by (Responsible Party):
Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief Summary:
Thin endometrium will lead to hypomenorrhea,infertility and recurrent pregnancy loss and there are few effective methods to increase the endometrial thickness and improve the fertility outcomes. Patients with thin endometrium will be divided into three groups and receive estrogen therapy, stem cell therapy and growth factor therapy respectively. This randomized controlled clinical study is carried out to explore the optimal treatment method and best indications for thin endometrium.

Condition or disease Intervention/treatment Phase
Infertility, Female, of Uterine Origin Endometrial Fibrosis Drug: CBD-bFGF Drug: Collagen/BMMNCs Drug: Estrogen Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of in Situ Regeneration of Endometrium
Actual Study Start Date : April 29, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Estrogens

Arm Intervention/treatment
Experimental: CBD-bFGF Drug: CBD-bFGF
CBD-bFGF will be injected into the endometrium after hysteroscopy under the guidance of ultrasound

Experimental: Collagen/BMMNCs Drug: Collagen/BMMNCs
A collagen scaffold loaded with BMMNCs will be transplanted into the uterine cavity after hysteroscopy under the guidance of ultrasound

Experimental: Estrogen Drug: Estrogen
Patients will receive regular estrogen therapy




Primary Outcome Measures :
  1. Endometrial thickness [ Time Frame: 6 months ]
    Endometrial thickness evaluated by transvaginal sonography during late proliferative phase

  2. Ongoing pregnancy rate [ Time Frame: 24 months ]
    The presence of a living intrauterine fetus on TVU at the 12th week of gestation


Secondary Outcome Measures :
  1. Endometrial blood flow [ Time Frame: 6 months ]
    Endometrial blood flow evaluated by transvaginal sonography

  2. Pregnancy related complications [ Time Frame: 24 months ]
    Miscarriage rate, live birth rate, ET cycle cancellation rate,Placenta related complications

  3. Histological changes of endometrium [ Time Frame: 12 months ]
    Histological changes of the thin endometrium before and after treatment

  4. Menstrual blood volume [ Time Frame: 6 months ]
    The change of menstrual blood volume after treatment compared with pre-treatment


Other Outcome Measures:
  1. Adverse event rate [ Time Frame: 24 months ]
    The occurrence of infections, allergies, abdominal pain, uterine perforation and etc.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.Patients with thin endometrium (4mm≤ EMT <7mm )or scarred endometrium (scarred area≤70%) which is nonresponsive to estrogen stimulation 2.Infertile patients with clear fertility desires 3.20-42 years old 4.Normal ovarian function or with frozen embryos 5.Willing to participate in follow-up

Exclusion Criteria:

  1. Endometrial thickness <4mm or scarred endometrial area>70%
  2. Uterine cavity out of shape and the cavity depth<6.5mm
  3. Abnormal chromosome karyotype
  4. Uterine diseases including large intramural myomas, severe endometriosis, severe adenomyosis, severe congenital uterine malformations, endometrial tuberculosis, vaginitis and endometritis
  5. Systemic diseases: hypertension, diabetes, and so on
  6. Contraindications to pregnancy
  7. Contraindications to hormone replacement therapy
  8. Medical history of pelvic tumors or receiving pelvic radiotherapy 9 .Involved in other clinical studies

10. Unable to adhere to the follow-up


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): NCT04233892


Locations
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China, Jiangsu
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
Yali Hu
Chinese Academy of Sciences
Investigators
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Principal Investigator: Yali Hu, MD,PhD The Affiliated Drum Tower Hospital of Nanjing University
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Responsible Party: Yali Hu, Professor,Chief Physician of Obstetrics and Gynecology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT04233892    
Other Study ID Numbers: SC201900202
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yali Hu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:
thin endometrium
infertility
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs