Recurrent Implantation FailureNCT03365466
Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women
An observational study of Recurrent Implantation Failure, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Recurrent Implantation Failure
- What is being tested?
- Low dose aspirin, Low molecular weight heparin and Low dose aspirin plus low molecular weight heparin
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2017to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- ≥3 pervious IVF-ET failures or failure with transfer of at least 10 frozen embryos in multiple transfers;
- 25-45 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai first Maternity and Infant health hospital, Tong Ji University
Shanghai, 200051
About this study
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.
Read the 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.
- Conditions
- Recurrent Implantation Failure
- Being tested
- Low dose aspirin, Low molecular weight heparin, Low dose aspirin plus low molecular weight heparin, no treatment
- Keywords
- recurrent implantation failure, aspirin, low molecular weight heparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose aspirinDrug
LDA 25mg tid
Low molecular weight heparinDrug
LMWH 5000u IH qd
Low dose aspirin plus low molecular weight heparinDrug
LDA 25mg tid + LMWH 5000u IH qd
no treatmentDrug
Patients who did not receive any treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Patients who received a daily dose of 75mg LDA per day after menstruation prior to ET. Receives: Drug: Low dose aspirin | |
| Group B | Patients who received a daily dose of 5000u LMWH after menstruation prior to ET. Receives: 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. Receives: Drug: Low dose aspirin plus low molecular weight heparin | |
| Group D | Patients who did not receive any treatment. Receives: Drug: no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Ongoing pregnancy beyond the 12th gestational week rate
Measured: until 12 weeks
Secondary outcomes (2)
Uterine artery blood flow
by transvaginal sonography
Measured: luteal phase before ET and one day before ET
Implantation rate
by transvaginal sonography
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Implantation FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shihua Bao, Shanghai First Maternity and Infant Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365466
- Sponsor's protocol ID
- ShanghaiFMIH-uRIF
- Status last verified
- Sep 2017
- First submitted
- 2 Dec 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women
- ClinicalTrials.gov ID
- NCT03365466
- Acronym / sponsor ID
- ShanghaiFMIH-uRIF
- Conditions
- Recurrent Implantation Failure
- Keywords
- recurrent implantation failure, aspirin, low molecular weight heparin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: Low dose aspirinPatients who received a daily dose of 75mg LDA per day after menstruation prior to ET. |
| Group B | – | Drug: Low molecular weight heparinPatients who received a daily dose of 5000u LMWH after menstruation prior to ET. |
| Group C | – | Drug: Low dose aspirin plus low molecular weight heparinPatients who received a daily dose of 75 mg LDA plus 5000u LMWH after menstruation prior to ET. |
| Group D | – | Drug: no treatmentPatients who did not receive any treatment. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- ≥3 pervious IVF-ET failures or failure with transfer of at least 10 frozen embryos in multiple transfers;
- 25-45 years old;
- Having a regular menstrual cycle and BBT;
- Top-quality frozen embryos for transfer;
- Endometrial thickness 8-14mm；
Key exclusion criteria (7 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose aspirinLDA 25mg tid | Drug | Group A |
| Low molecular weight heparinLMWH 5000u IH qd | Drug | Group B |
| Low dose aspirin plus low molecular weight heparinLDA 25mg tid + LMWH 5000u IH qd | Drug | Group C |
| no treatmentPatients who did not receive any treatment. | Drug | Group D |
Primary outcome
Clinical pregnancy rate
Time frame: until 12 weeks
Ongoing pregnancy beyond the 12th gestational week rate
2 secondary outcomes
Uterine artery blood flow
Time frame: luteal phase before ET and one day before ET
Implantation rate
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Implantation Failure, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shihua Bao, PhD (86-21-20261430 ext. 2012, baoshihua@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: until 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.