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

NCT ID: NCT04741295

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2022-01-31

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.

Conditions

Adenomyosis; Assisted Reproductive Technology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

Adenomyosis patients in control group have normal luteal progesterone support.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Low molecular weight heparin

Intervention Type: DRUG

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

Interventions

Low molecular weight heparin

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nanjing University

OTHER

Sponsor Role: lead

Responsible Party

Li-jun Ding

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

SZ-2021-ADE1

Identifier Type: -

Identifier Source: org_study_id