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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03365466
Enrollment
200
Registered
2017-12-07
Start date
2017-12-31
Completion date
2019-02-28
Last updated
2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Implantation Failure

Keywords

recurrent implantation failure, aspirin, low molecular weight heparin

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.

Detailed description

Infertility is a growing issue for many couples all over the world. Nowadays, Assisted reproductive technology is widely used to treat couples affected by infertility, but, the success rate is still very low. Recurrent implantation failure is an important cause of repeated IVF failure. In addition to the embryo quality, a functioning and receptive endometrium is crucial for embryo implantation. There is a growing amount of evidence shows that uterine perfusion playing an important part in regulating endometrial receptivity and in successful pregnancy. Recently, transvaginal ultrasonography is often used to examine endometrial thickness, pattern and blood flow status to predict uterine receptivity. Some studies have demonstrated that uterine artery blood flow resistance in RM (Recurrent miscarriage) patients is significantly higher than in normal fertile patients. It has been postulated that abnormal uterine perfusion could be related to the reproductive failure, enhancing the uterine perfusion may improve the successful pregnancy. In accordance with this hypothesis, some therapeutic approaches including low dose aspirin (LDA), nitric oxide donor, low molecular weight heparin, sildenafil are applying in clinic. Low molecular weight heparin (LMWH) is derived from unfractionated heparin. It also has anticoagulation or the antithrombin effect. Aspirin has analgesic, antipyretic, and anti-inflammatory properties. Initially, aspirin and low molecular weight heparin have been used either as single agents or in combination to treat patients with recurrent miscarriage, diagnosed with antiphospholipid syndrome. The treatment confers a significant benefit in live births rate. Furthermore, various studies have shown that thrombophilia are more common in women with RIF compared with healthy fertile controls. In these women, heparin treatment could potentially enhance the implantation process, and may finally improve the live birth rate. 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.

Interventions

LDA 25mg tid

DRUGLow molecular weight heparin

LMWH 5000u IH qd

DRUGLow dose aspirin plus low molecular weight heparin

LDA 25mg tid + LMWH 5000u IH qd

DRUGno treatment

Patients who did not receive any treatment.

Sponsors

Shanghai First Maternity and Infant Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

1. ≥3 pervious IVF-ET failures or failure with transfer of at least 10 frozen embryos in multiple transfers; 2. 25-45 years old; 3. Having a regular menstrual cycle and BBT; 4. Top-quality frozen embryos for transfer; 5. Endometrial thickness 8-14mm; 6. Abnormal uterine perfusion(PI\>2.5); 7. Decided to recieve LMWH or LDA or a combination of LMWH and LDA therapy.

Exclusion criteria

1. Chromosome aberrations in anyone of the couple; 2. Abnormal uterine cavity; 3. Hydrosalpinx; 4. Chronic systemic disease(liver,renal,heart,thyroid and thrombocytopenia) 5. Having experienced severe allergies, trauma history; 6. With a history of mental illness; 7. Any contraindication for LDA or LMWH.

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy rateuntil 12 weeksOngoing pregnancy beyond the 12th gestational week rate

Secondary

MeasureTime frameDescription
Uterine artery blood flowluteal phase before ET and one day before ETby transvaginal sonography
Implantation rate8 weeksby transvaginal sonography

Countries

China

Contacts

Primary ContactShihua Bao, PhD
baoshihua@tongji.edu.cn86-21-20261430

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026