InfertilityPhase 2/3NCT01315093
Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation
A Phase 2/3 study testing Heparin, Low-Molecular-Weight and no heparin in people with Infertility, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF) Read more about this study
- Who is it for?
- Ages 25 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Heparin, Low-Molecular-Weight and no heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2010to Jun 2016
- Phase
- Phase 2/3
- 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 25 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- poor responders (age>40, abnormal ovarian test, </=4 oocytes in previous cycle with conventional stimulation)
- infertility, indication for IVF
- no contraindications for heparin
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)
- Conditions
- Infertility
- Being tested
- Heparin, Low-Molecular-Weight, no heparin
- Keywords
- In Vitro Fertilisation, poor responders
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin, Low-Molecular-WeightDrug
Heparin from start till hcg test
no heparinDrug
| Study group | Role | What they receive |
|---|---|---|
| Heparin, Low-Molecular-Weight group | Experimental | LMWH was administered during an IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders. Drug was started at the beginning of the cycle and stopped at the time of pregnancy test if negative, or continued if pregnancy occurred until the 32th weeks of gestation Receives: Drug: Heparin, Low-Molecular-Weight |
| Non Heparin, Low-Molecular-Weight group | Active comparator | IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders. Receives: Drug: no heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
no of oocytes retrieved
>2 between groups
Measured: egg recovery, 2 years
Secondary outcomes (4)
clinical pregnancy rate
Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
Measured: 2 years
live birth rate
>20 weeks of gestation
Measured: 2 years
cancellation rate
Measured: before ET, 2 years
miscarriage rate
pregnancy loss <20 weeks
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315093
- Sponsor's protocol ID
- 123456
- Status last verified
- Mar 2016
- First submitted
- 8 Mar 2011
- Last updated
- 1 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation
- ClinicalTrials.gov ID
- NCT01315093
- Acronym / sponsor ID
- 123456
- Conditions
- Infertility
- Keywords
- In Vitro Fertilisation, poor responders
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Mar 2011 (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 addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin, Low-Molecular-Weight group | Experimental | Drug: Heparin, Low-Molecular-WeightLMWH was administered during an IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders. Drug was started at the beginning of the cycle and stopped at the time of pregnancy test if negative, or continued if pregnancy occurred until the 32th weeks of gestation |
| Non Heparin, Low-Molecular-Weight group | Active comparator | Drug: no heparinIVF cycle using either the GnRH - agonist or antagonist protocol in poor responders. |
Who may qualify
- Ages
- 25 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- poor responders (age>40, abnormal ovarian test, </=4 oocytes in previous cycle with conventional stimulation)
- infertility, indication for IVF
- no contraindications for heparin
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Heparin, Low-Molecular-WeightHeparin from start till hcg test | Drug | Heparin, Low-Molecular-Weight group |
| no heparin | Drug | Non Heparin, Low-Molecular-Weight group |
Primary outcome
no of oocytes retrieved
Time frame: egg recovery, 2 years
>2 between groups
4 secondary outcomes
clinical pregnancy rate
Time frame: 2 years
live birth rate
Time frame: 2 years
cancellation rate
Time frame: before ET, 2 years
miscarriage rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Heparin, Low-Molecular-Weight and no heparin in people with Infertility, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 1 May 2018. 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 Greece. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
no of oocytes retrieved (time frame: egg recovery, 2 years). 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 1 May 2018.