Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women
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|ClinicalTrials.gov Identifier: NCT03365466|
Recruitment Status : Not yet recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment|
|Recurrent Implantation Failure||Drug: Low dose aspirin Drug: Low molecular weight heparin Drug: Low dose aspirin plus low molecular weight heparin Drug: no treatment|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women|
|Estimated Study Start Date :||December 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
Patients who received a daily dose of 75mg LDA per day after menstruation prior to ET.
Drug: Low dose aspirin
LDA 25mg tid
Patients who received a daily dose of 5000u LMWH after menstruation prior to ET.
Drug: Low molecular weight heparin
LMWH 5000u IH qd
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
LDA 25mg tid + LMWH 5000u IH qd
Patients who did not receive any treatment.
Drug: no treatment
Patients who did not receive any treatment.
- Clinical pregnancy rate [ Time Frame: until 12 weeks ]Ongoing pregnancy beyond the 12th gestational week rate
- Uterine artery blood flow [ Time Frame: luteal phase before ET and one day before ET ]by transvaginal sonography
- Implantation rate [ Time Frame: 8 weeks ]by transvaginal sonography
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365466
|Contact: Shihua Bao, PhD||86-21-20261430 ext firstname.lastname@example.org|
|Shanghai first Maternity and Infant health hospital, Tong Ji University|
|Shanghai, China, 200051|