Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women

NCT03365466 | Unknown

• 1 other identifier: ShanghaiFMIH-uRIF
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate whether Low Dose Aspirin and Low Molecular Weight Heparin could increase the uterine perfusion, and finally improve the implantation and pregnancy rates in patients with unexplained recurrent implantation failure.

Conditions

Recurrent Implantation Failure

Keywords

recurrent implantation failure; aspirin; low molecular weight heparin

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Ongoing pregnancy beyond the 12th gestational week rate

  until 12 weeks

Secondary Outcomes (2)

• Uterine artery blood flow

  luteal phase before ET and one day before ET

• Implantation rate

  8 weeks

Study Arms (4)

Group A

Patients who received a daily dose of 75mg LDA per day after menstruation prior to ET.

Drug: Low dose aspirin

Group B

Patients who received a daily dose of 5000u LMWH after menstruation prior to ET.

Drug: Low molecular weight heparin

Group C

Patients who received a daily dose of 75 mg LDA plus 5000u LMWH after menstruation prior to ET.

Drug: Low dose aspirin plus low molecular weight heparin

Group D

Patients who did not receive any treatment.

Drug: no treatment

Interventions

Low dose aspirin DRUG

LDA 25mg tid

Group A

Low molecular weight heparin DRUG

LMWH 5000u IH qd

Group B

Low dose aspirin plus low molecular weight heparin DRUG

LDA 25mg tid + LMWH 5000u IH qd

Group C

no treatment DRUG

Patients who did not receive any treatment.

Group D

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This is a prospective cohort study on unexplained recurrent implantation failure patients with abnormal uterine perfusion in our clinic from September 2017 to December 2018.

You may qualify if:

• ≥3 pervious IVF-ET failures or failure with transfer of at least 10 frozen embryos in multiple transfers;
• years old;
• Having a regular menstrual cycle and BBT;
• Top-quality frozen embryos for transfer;
• Endometrial thickness 8-14mm；
• Abnormal uterine perfusion(PI\>2.5)；
• Decided to recieve LMWH or LDA or a combination of LMWH and LDA therapy.

You may not qualify if:

• Chromosome aberrations in anyone of the couple;
• Abnormal uterine cavity;
• Hydrosalpinx;
• Chronic systemic disease(liver,renal,heart,thyroid and thrombocytopenia)
• Having experienced severe allergies, trauma history；
• With a history of mental illness;
• Any contraindication for LDA or LMWH.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Study Sites (1)

Shanghai first Maternity and Infant health hospital, Tong Ji University

Shanghai, 200051, China

Location

MeSH Terms

Interventions

Aspirin; Heparin, Low-Molecular-Weight

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Shihua Bao, PhD

CONTACT

86-21-20261430; baoshihua@tongji.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2017
• First Posted: December 7, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: December 7, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)