InfertilityNCT00750451
Low Molecular Weight Heparin in Recurrent Implantation Failure
A study testing low molecular weight heparin (enoxaparine sodium) and crinone 8% gel in people with Infertility and Fertilization in Vitro, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
Recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts with in vitro fertilization treatment. The reason is usually obscure. Many empirical treatments have been offered without substantial evaluation. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, Fertilization in Vitro, Recurrent Implantation Failure
- What is being tested?
- low molecular weight heparin (enoxaparine sodium) and crinone 8% gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2006to May 2008
- Phase
- Interventional
- 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 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- History of at least two previously failed fresh embryo transfer cycles
- All previously failed cycles to be performed in the American Hospital of Istanbul
- Female age ≤ 38 years
- Fresh ejaculate sperms to be used for ICSI
- No hormonal, coagulation, or immunological disorders detected
- Normal uterine cavity, as assessed by diagnostic office hysteroscopy or saline infusion sonography
- Normal female and male peripheral karyotype
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Assisted Reproduction Unit of the American Hospital of Istanbul
Istanbul, 34365
About this study
Official title: Empirical Low Molecular Weight Heparin Administration in the Luteal Phase in Patients With Recurrent Implantation Failures: a Randomized Open Labeled Trial
Recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts with in vitro fertilization treatment. The reason is usually obscure. Many empirical treatments have been offered without substantial evaluation. Heparin is thought to play a role in the embryo implantation process beyond its anticoagulation effects. The proposed study aims to assess the effectiveness and safety of empirical administration of low molecular weight heparin in patients undergoing a new IVF treatment cycle after multiple failed attempts.
- Being tested
- low molecular weight heparin (enoxaparine sodium), crinone 8% gel
- Keywords
- fertilization in vitro, assisted reproduction, recurrent implantation failure, low molecular weight heparin, heparin, luteal phase
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low molecular weight heparin (enoxaparine sodium)Drug
1 mg/kg/day subcutaneously in the luteal phase after IVF treatment
crinone 8% gelDrug
routine luteal phase support with progesterone gel
| Study group | Role | What they receive |
|---|---|---|
| LMWH | Experimental | Women in the LMWH arm are administered 1 mg/kg/day subcutaneously low molecular weight heparin after oocyte collection in addition to routine luteal phase support with vaginal progesterone Receives: Drug: low molecular weight heparin (enoxaparine sodium) |
| Control | Active comparator | Women in the control arm are administered routine luteal phase support without the addition of LMWH Receives: Drug: crinone 8% gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy beyond the 20th gestational week rate
Secondary outcomes (2)
Clinical pregnancy rate
Embryo implantation rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startJan 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
Sponsor and investigators
- Lead sponsor
- V.K.V. American Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Investigators
- Cumhur B Urman, M.D., Study director, American Hospital of Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750451
- Sponsor's protocol ID
- AH-05/11
- Status last verified
- Mar 2009
- First submitted
- 9 Sep 2008
- Last updated
- 20 Mar 2009
- Results posted
- No
Publications
Urman B, Ata B, Yakin K, Alatas C, Aksoy S, Mercan R, Balaban B. Luteal phase empirical low molecular weight heparin administration in patients with failed ICSI embryo transfer cycles: a randomized open-labeled pilot trial. Hum Reprod. 2009 Jul;24(7):1640-7. doi: 10.1093/humrep/dep086. Epub 2009 Apr 8.
PubMed 19357135
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empirical Low Molecular Weight Heparin Administration in the Luteal Phase in Patients With Recurrent Implantation Failures: a Randomized Open Labeled Trial
- ClinicalTrials.gov ID
- NCT00750451
- Acronym / sponsor ID
- AH-05/11
- Keywords
- fertilization in vitro, assisted reproduction, recurrent implantation failure, low molecular weight heparin, heparin, luteal phase
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- V.K.V. American Hospital, IstanbulUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Sep 2008 (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.
Recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts with in vitro fertilization treatment. The reason is usually obscure. Many empirical treatments have been offered without substantial evaluation. Heparin is thought to play a role in the embryo implantation process beyond its anticoagulation effects. The proposed study aims to assess the effectiveness and safety of empirical administration of low molecular weight heparin in patients undergoing a new IVF treatment cycle after multiple failed attempts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMWH | Experimental | Drug: low molecular weight heparin (enoxaparine sodium)Women in the LMWH arm are administered 1 mg/kg/day subcutaneously low molecular weight heparin after oocyte collection in addition to routine luteal phase support with vaginal progesterone |
| Control | Active comparator | Drug: crinone 8% gelWomen in the control arm are administered routine luteal phase support without the addition of LMWH |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- History of at least two previously failed fresh embryo transfer cycles
- All previously failed cycles to be performed in the American Hospital of Istanbul
- Female age ≤ 38 years
- Fresh ejaculate sperms to be used for ICSI
- No hormonal, coagulation, or immunological disorders detected
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 |
|---|---|---|
| low molecular weight heparin (enoxaparine sodium)1 mg/kg/day subcutaneously in the luteal phase after IVF treatment | Drug | LMWH |
| crinone 8% gelroutine luteal phase support with progesterone gel | Drug | Control |
Primary outcome
Ongoing pregnancy beyond the 20th gestational week rate
2 secondary outcomes
Clinical pregnancy rate
Embryo implantation rate
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 20 Mar 2009.
- Derived from this study: PubMed 19357135Urman B, Ata B, Yakin K, Alatas C, Aksoy S, Mercan R, Balaban B. Luteal phase empirical low molecular weight heparin administration in patients with failed ICSI embryo transfer cycles: a randomized open-labeled pilot trial. Hum Reprod. 2009 Jul;24(7):1640-7. doi: 10.1093/humrep/dep086. Epub 2009 Apr 8.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Cumhur B Urman, M.D. study director
American Hospital of Istanbul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low molecular weight heparin (enoxaparine sodium) and crinone 8% gel in people with Infertility and Fertilization in Vitro, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
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 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 20 Mar 2009. 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 Turkey (Türkiye). 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?
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?
Ongoing pregnancy beyond the 20th gestational week rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750451, which also lists 1 linked publication.
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 20 Mar 2009.