To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out ComePhase 3NCT01924104
Effects of Aspirin and Low Molecular Weight Heparin in IVF Outcome.
A Phase 3 study testing Low molecular weight heparin, Low dose aspirin and Heparin & aspirin in people with To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come, run by Dr.Vandana Bansal at 1 site in India.
Trial summary
The purpose of the study is to determine whether low-dose aspirin and low molecular weight heparin improve the implantation and pregnancy rates in patients with repeated implantation failures in IVF cycle. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women only
- Conditions the study is for
- To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come
- What is being tested?
- Low molecular weight heparin, Low dose aspirin and Heparin & aspirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 3
- 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 19 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 19 to 35 years;
- Basal follicle-stimulating hormone (FSH) levels of ≤8 IU/l
- Body mass index (BMI) between 19 kg/m2 and 25 kg/m2
- Presence of both ovaries; ≥2 previous IVF failures
- Good quality embryos for transfer
- Endometrial thickness between 10 mm and 14 mm
Who cannot join
- Polycystic ovary syndrome
- Endometriosis
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Arpit Test Tube Baby Centre, Jeevan Jyoti Hospital & Research Centre
Allahābād, Uttar Pradesh, 211003
Vandana Bansal, MS DGO PhD, +91-0532-2417252 ext. 402, bansal.drvandana@gmail.com
Ashwani K Bansal, MS, +91-0532-2417252 ext. 403, arpitivf@gmail.com
About this study
Official title: Effects of Low Dose Aspirin and Low Molecular Weight Heparin Cotreatment, Alone and/or in Combination on Implantation and Clinical Pregnancy Rates in Repeated Implantation Failures in IVF Cycle.
The purpose of the study is to determine whether low-dose aspirin and low molecular weight heparin improve the implantation and pregnancy rates in patients with repeated implantation failures in IVF cycle.
Read the detailed description
The investigators hypothesize that cotreatment of low dose aspirin \& low molecular weight heparin may improve implantation \& clinical pregnancy rates.
- Conditions
- To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come
- Being tested
- Low molecular weight heparin, Low dose aspirin, Heparin & aspirin, NaCl
- Keywords
- IVF failure, implantation rate, heparin & aspirin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low molecular weight heparinDrug
Also called LMWH
2500 mIU/day, subcutaneously
Low dose aspirinDrug
Also called Ecoaspirin
75 mg/day, orally
Heparin & aspirinDrug
Also called LMWH & Ecoaspirin
Aspirin (70 mg/day, orally) \& heparin (40 mg/day, subcutaneously)
NaClOther
Equivalent volume of NaCl 0.9%, subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Low Molecular Weight Heparin | Active comparator | Low molecular weight heparin, 2500 milli-International unit/day, subcutaneously Receives: Drug: Low molecular weight heparin |
| Low dose aspirin | Active comparator | Low dose aspirin, 75mg/day, orally Receives: Drug: Low dose aspirin |
| Heparin & Aspirin | Active comparator | Heparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally) Receives: Drug: Heparin & aspirin |
| Sodium chloride (NaCl) | Placebo comparator | Equivalent volume of NaCl 0.9%, subcutaneously Receives: Other: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological pregnancy test
Measured: 14 days
Secondary outcomes (1)
Fetal heart/Gestational sac
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 posted16 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out ComeStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr.Vandana Bansal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr.Vandana Bansal, Jeevan Jyoti Hospital
- Investigators
- Vandana Bansal, MS DGO PhD, Principal investigator, Arpit Test Tube Baby Centre, Vandana Women's Hospital, Jeevan Jyoti Hospital & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924104
- Sponsor's protocol ID
- JJH2013
- Status last verified
- Aug 2013
- First submitted
- 12 Aug 2013
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Dose Aspirin and Low Molecular Weight Heparin Cotreatment, Alone and/or in Combination on Implantation and Clinical Pregnancy Rates in Repeated Implantation Failures in IVF Cycle.
- ClinicalTrials.gov ID
- NCT01924104
- Acronym / sponsor ID
- JJH2013
- Conditions
- To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come
- Keywords
- IVF failure, implantation rate, heparin & aspirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Dr.Vandana BansalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 16 Aug 2013 (estimated)
- 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 purpose of the study is to determine whether low-dose aspirin and low molecular weight heparin improve the implantation and pregnancy rates in patients with repeated implantation failures in IVF cycle.
Detailed description
The investigators hypothesize that cotreatment of low dose aspirin \& low molecular weight heparin may improve implantation \& clinical pregnancy rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Molecular Weight Heparin | Active comparator | Drug: Low molecular weight heparinLow molecular weight heparin, 2500 milli-International unit/day, subcutaneously |
| Low dose aspirin | Active comparator | Drug: Low dose aspirinLow dose aspirin, 75mg/day, orally |
| Heparin & Aspirin | Active comparator | Drug: Heparin & aspirinHeparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally) |
| Sodium chloride (NaCl) | Placebo comparator | Other: NaClEquivalent volume of NaCl 0.9%, subcutaneously |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 19 to 35 years;
- Basal follicle-stimulating hormone (FSH) levels of ≤8 IU/l
- Body mass index (BMI) between 19 kg/m2 and 25 kg/m2
- Presence of both ovaries; ≥2 previous IVF failures
- Good quality embryos for transfer
Key exclusion criteria (2 listed)
- Polycystic ovary syndrome
- Endometriosis
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 molecular weight heparinAlso: LMWH2500 mIU/day, subcutaneously | Drug | Low Molecular Weight Heparin |
| Low dose aspirinAlso: Ecoaspirin75 mg/day, orally | Drug | Low dose aspirin |
| Heparin & aspirinAlso: LMWH & EcoaspirinAspirin (70 mg/day, orally) \& heparin (40 mg/day, subcutaneously) | Drug | Heparin & Aspirin |
| NaClEquivalent volume of NaCl 0.9%, subcutaneously | Other | Sodium chloride (NaCl) |
Primary outcome
Biological pregnancy test
Time frame: 14 days
1 secondary outcome
Fetal heart/Gestational sac
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 16 Aug 2013.
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.
Vandana Bansal, MS DGO PhD principal investigator
Arpit Test Tube Baby Centre, Vandana Women's Hospital, Jeevan Jyoti Hospital & Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low molecular weight heparin, Low dose aspirin and Heparin & aspirin in people with To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come, run by Dr.Vandana Bansal at 1 site in India.
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 6 inclusion and 2 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 16 Aug 2013. 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 India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Vandana Bansal, MS DGO PhD (+91-0532-2417252 ext. 402, bansal.drvandana@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological pregnancy test (time frame: 14 days). 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 16 Aug 2013.