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

Not Applicable

• Conditions: Assisted Reproductive Technology; Adenomyosis
• Interventions: Drug: Low molecular weight heparin

• Registration Number: NCT04741295
• Lead Sponsor: Nanjing University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Status Verified: 2021-02
• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-03
• Last Update Submitted: 2021-02-03
• Study First Posted: 2021-02-05
• Last Update Posted: 2021-02-05
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Early spontaneous abortion rate	Within three months after frozen embryo transfer

Trial Locations

Locations (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China