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

Recurrent Implantation Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03365466
• Other study ID #: ShanghaiFMIH-uRIF
• Status: Not yet recruiting
• Phase: N/A
• First received: December 2, 2017
• Last updated: December 6, 2017
• Start date: December 2017
• Est. completion date: February 2019

Study information

• Verified date: September 2017
• Source: Shanghai First Maternity and Infant Hospital
• Contact: Shihua Bao, PhD
• Phone: 86-21-20261430
• Email: baoshihua[@]tongji.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrent Implantation Failure

Intervention

Drug:
• Low dose aspirin
LDA 25mg tid
• Low molecular weight heparin
LMWH 5000u IH qd
• Low dose aspirin plus low molecular weight heparin
LDA 25mg tid + LMWH 5000u IH qd
• no treatment
Patients who did not receive any treatment.

Locations

Country	Name	City	State
China	Shanghai first Maternity and Infant health hospital, Tong Ji University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Ongoing pregnancy beyond the 12th gestational week rate	until 12 weeks
Secondary	Uterine artery blood flow	by transvaginal sonography	luteal phase before ET and one day before ET
Secondary	Implantation rate	by transvaginal sonography	8 weeks