deltatrials
Unknown OBSERVATIONAL NCT03365466

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

Sponsor: Shanghai First Maternity and Infant Hospital

Updated 7 times since 2017 Last updated: Dec 6, 2017 Started: Dec 31, 2017 Primary completion: Dec 31, 2018 Completion: Feb 28, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Recurrent Implantation Failure and is currently ongoing. Shanghai First Maternity and Infant Hospital leads this study, which shows 7 recorded versions since 2017 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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,...

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.

Status Flow

~Dec 2017 – ~Apr 2018 · 4 months · monthly snapshotNot Yet Recruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotNot Yet Recruiting~Jun 2018 – ~Oct 2019 · 16 months · monthly snapshotNot Yet Recruiting~Oct 2019 – ~Jan 2021 · 15 months · monthly snapshotUnknown Status~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Unknown

  2. Jul 2024 — Sep 2024 [monthly]

    Unknown

    Status: Unknown StatusUnknown

  3. Jan 2021 — Jul 2024 [monthly]

    Unknown Status

  4. Oct 2019 — Jan 2021 [monthly]

    Unknown Status

    Status: Not Yet RecruitingUnknown Status

  5. Jun 2018 — Oct 2019 [monthly]

    Not Yet Recruiting

Show 2 earlier versions
  1. Apr 2018 — Jun 2018 [monthly]

    Not Yet Recruiting

    Phase: NANone

  2. Dec 2017 — Apr 2018 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shanghai First Maternity and Infant Hospital
Data source: Shanghai First Maternity and Infant Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations