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

Adenomyosis Clinical Trial

Official title:

To Study the Effect of Low Molecular Weight Heparin on the Adenomyosis Patients'Outcome of in Vitro Fertilization-embryo Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04741295
• Other study ID #: SZ-2021-ADE1
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2021
• Source: Nanjing University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Assisted Reproductive Technology

Intervention

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.

Locations

Country	Name	City	State
China	Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early spontaneous abortion rate		Within three months after frozen embryo transfer