Low Molecular Weight Heparin on the Adenomyosis Patients'IVF-ET Outcome

Sponsor
Nanjing University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04741295
Collaborator
(none)
70
1
2
24
2.9

Study Details

Study Description

Brief Summary

In assisted reproductive technology, adenomyosis patients are characterized by lower clinical pregnancy rate, lower implantation rate and higher abortion rate. The purpose of this study is to explore whether low molecular weight heparin can reduce the abortion rate of adenomyosis patients in frozen thawed embryo transfer cycles.

Condition or Disease Intervention/Treatment Phase
  • Drug: Low molecular weight heparin
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
To Study the Effect of Low Molecular Weight Heparin on the Adenomyosis Patients'Outcome of in Vitro Fertilization-embryo Transplantation
Actual Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

Adenomyosis patients in control group have normal luteal progesterone support.

Experimental: Low molecular weight heparin Group

Adenomyosis patients in Low molecular weight heparin group have Low molecular weight heparin in addition to normal luteal progesterone support.

Drug: Low molecular weight heparin
Patients with adenomyosis were treated with low molecular weight heparin after frozen embryo transfer in addition to routine luteal support.

Outcome Measures

Primary Outcome Measures

  1. Early spontaneous abortion rate [Within three months after frozen embryo transfer]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 38 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. The basal serum level of FSH was less than 10 IU / L

  2. Diagnosed with adenomyosis by ultrasound

  3. The first frozen thawed embryo transfer cycle, by hormone replacement protocol

  4. Transfer at least one high quality frozen embryo;

  5. Patients agreed to use low molecular weight heparin after FET, and they were able to sign informed consent in person.

Exclusion Criteria:
  1. With abnormal karyotype;

  2. Accompanied with other uterine diseases: intrauterine adhesion, intramural myoma, moderate to severe endometriosis, congenital uterine malformation, endometrial tuberculosis, thin endometrium < 8mm on the day of transformation, etc;

  3. PCOS, RIF patients;

  4. There are indications of conventional anticoagulation or antiplatelet therapy, such as antiphospholipid syndrome, autoimmune diseases, coagulation dysfunction, etc;

  5. There were contraindications to hormone replacement therapy and low molecular weight heparin;

  6. Participating in other clinical studies;

  7. Unable to follow-up

Contacts and Locations

Locations

Site City State Country Postal Code
1 Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School Nanjing Jiangsu China 210008

Sponsors and Collaborators

  • Nanjing University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Li-jun Ding, Professor, Nanjing University
ClinicalTrials.gov Identifier:
NCT04741295
Other Study ID Numbers:
  • SZ-2021-ADE1
First Posted:
Feb 5, 2021
Last Update Posted:
Feb 5, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 5, 2021