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

NCT04741295 | Unknown

• 1 other identifier: SZ-2021-ADE1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Early spontaneous abortion rate

  Within three months after frozen embryo transfer

Study Arms (2)

Control Group

NO INTERVENTION

Adenomyosis patients in control group have normal luteal progesterone support.

Low molecular weight heparin Group

EXPERIMENTAL

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

Interventions

Low molecular weight heparin DRUG

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

Low molecular weight heparin Group

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing University: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Adenomyosis

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 5, 2021
• Study Start: February 1, 2020
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)