Back to resultsLow Molecular Weight Heparin on the Adenomyosis Patients'IVF-ET Outcome
Primary Purpose
Adenomyosis, Assisted Reproductive Technology
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low molecular weight heparin
Sponsored by
About this trial
This is an interventional treatment trial for Adenomyosis
Eligibility Criteria
Inclusion Criteria:
- The basal serum level of FSH was less than 10 IU / L
- Diagnosed with adenomyosis by ultrasound
- The first frozen thawed embryo transfer cycle, by hormone replacement protocol
- Transfer at least one high quality frozen embryo;
- Patients agreed to use low molecular weight heparin after FET, and they were able to sign informed consent in person.
Exclusion Criteria:
- With abnormal karyotype;
- 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;
- PCOS, RIF patients;
- There are indications of conventional anticoagulation or antiplatelet therapy, such as antiphospholipid syndrome, autoimmune diseases, coagulation dysfunction, etc;
- There were contraindications to hormone replacement therapy and low molecular weight heparin;
- Participating in other clinical studies;
- Unable to follow-up
Sites / Locations
- Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Low molecular weight heparin Group
Arm Description
Adenomyosis patients in control group have normal luteal progesterone support.
Adenomyosis patients in Low molecular weight heparin group have Low molecular weight heparin in addition to normal luteal progesterone support.
Outcomes
Primary Outcome Measures
Early spontaneous abortion rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04741295
Brief Title
Low Molecular Weight Heparin on the Adenomyosis Patients'IVF-ET Outcome
Official Title
To Study the Effect of Low Molecular Weight Heparin on the Adenomyosis Patients'Outcome of in Vitro Fertilization-embryo Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis, Assisted Reproductive Technology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Adenomyosis patients in control group have normal luteal progesterone support.
Arm Title
Low molecular weight heparin Group
Arm Type
Experimental
Arm Description
Adenomyosis patients in Low molecular weight heparin group have Low molecular weight heparin in addition to normal luteal progesterone support.
Intervention Type
Drug
Intervention Name(s)
Low molecular weight heparin
Intervention Description
Patients with adenomyosis were treated with low molecular weight heparin after frozen embryo transfer in addition to routine luteal support.
Primary Outcome Measure Information:
Title
Early spontaneous abortion rate
Time Frame
Within three months after frozen embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The basal serum level of FSH was less than 10 IU / L
Diagnosed with adenomyosis by ultrasound
The first frozen thawed embryo transfer cycle, by hormone replacement protocol
Transfer at least one high quality frozen embryo;
Patients agreed to use low molecular weight heparin after FET, and they were able to sign informed consent in person.
Exclusion Criteria:
With abnormal karyotype;
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;
PCOS, RIF patients;
There are indications of conventional anticoagulation or antiplatelet therapy, such as antiphospholipid syndrome, autoimmune diseases, coagulation dysfunction, etc;
There were contraindications to hormone replacement therapy and low molecular weight heparin;
Participating in other clinical studies;
Unable to follow-up
Facility Information:
Facility Name
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Low Molecular Weight Heparin on the Adenomyosis Patients'IVF-ET Outcome
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