SterilityPhase 4BRIFNCT02607319
Low Molecular Weight Heparin to Improve Pregnancy Outcome in Patients With Recurrent Implantation Failure
A Phase 4 study testing Bemiparin sodium in people with Sterility, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The objective of this study is to determine the effect of Bemiparin, a low molecular weight heparin, on implantation rate in women with unexplained recurrent implantation failure undergoing IVF/ICSI treatment. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Sterility
- What is being tested?
- Bemiparin sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteLebanon
- Study dates
- Nov 2015to Jul 2022
- Phase
- Phase 4
- 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 three or more consecutively failed In Vitro Fertilization (IVF) cycles after embryo transfer.
- Normal uterine cavity (as assessed by hysteroscopy or HSG).
- Normal hormonal investigation: TSH, PRL, FBS.
- Normal acquired/inherited thrombophilia profile: LAC, ACA IgG/IgM, Prot S, Antithrombin III, beta-2 glycoprotein, Factors V, II, MTHFR.
- Normal semen analysis and mild/moderate male factor (Total motile sperm count > 5 million/ml and/or normal WHO morphology >20%.
- Patient provides written informed consent.
Who cannot join
- Evidence of low ovarian reserve by at least one of the following: AMH ≤ 1,5 ng/mL and/or basal CD 3 FSH ≥ 10 mIU/mL and/or basal CD 3 Estradiol ≥ 60 ng/mL and/or previous egg collection yield ≤ 3 oocytes.
- Preexisting medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition…).
- Severe male factor infertility (Total motile sperm count < 5 million/ml and/or normal WHO morphology <20%).
- Hypersensitivity to Heparin or its derivatives.
- Acquired thrombophilia.
- Active hemorrhage or increased risk of bleeding due to impairment of homeostasis.
Show all 12Show fewer
- Severe impairment of liver or pancreatic function.
- Severe renal insufficiency (Creatinine Clearance < 30 ml/min).
- Injuries to or operations on the central nervous system, eyes and ears within the last 2 months.
- Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced thrombocytopenia.
- Acute bacterial endocarditis and endocarditis lenta.
- Any organic lesion with high risk of bleeding (e.g.: active peptic ulcer, hemorrhagic stroke, cerebral aneurysm or cerebral neoplasms).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low Molecular Weight Heparin (Bemiparin) on Implantation Rate in Patients With Recurrent Implantation Failure Undergoing IVF/ICSI - A Prospective Randomized Clinical Trial
The objective of this study is to determine the effect of Bemiparin, a low molecular weight heparin, on implantation rate in women with unexplained recurrent implantation failure undergoing IVF/ICSI treatment.
Read the detailed description
Recurrent implantation failure (RIF), defined as failure of conception following three or more consecutive In Vitro Fertilization (IVF) cycles despite the transfer of good quality embryos, is a major cause of distress amongst infertile couples. While factors underlying implantation failure are many, most cases remain unexplained. In order to improve pregnancy outcomes and delivery rates in women with unexplained RIF, various investigational treatments have been proposed.
The investigators propose a prospective controlled randomized comparative study to evaluate the effect of Bemiparin on implantation rates in women with unexplained RIF. A total of 200 patients will be recruited and randomized between two groups. The study group will receive Bemiparin plus standard care; while the control group will receive only standard care. Treatment will start on the day following embryo transfer and will be continued until 12 weeks gestation in the event of pregnancy.
The primary objective is to determine the effect of Bemiparin on implantation rate in women with unexplained recurrent implantation failure.
- Conditions
- Sterility
- Being tested
- Bemiparin sodium
- Keywords
- Recurrent Implantation Failure, Implantation, low molecular weight heparin, In vitro Fertilization, Assisted Reproductive Technology, Pregnancy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bemiparin sodiumDrug
Also called Hibor
Bemiparin sodium 3,500 IU will be started on the evening of the same day of embryo transfer and until the day of pregnancy test. If the test is positive, Bemiparin will be discontinued by the end of the 12th week of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Low molecular weight heparin | Experimental | Bemiparin sodium 3,500 IU anti Xa/0.2 ml solution (Hibor; Laboratories Rovi Pharmaceuticals) for injection in pre-filled syringes. Receives: Drug: Bemiparin sodium |
| No intervention group | No intervention | Control group receiving standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate (%)
Number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos
Measured: Vaginal ultrasound at 8 weeks gestation
Secondary outcomes (4)
Live birth rate (%)
birth of live born
Measured: Time of delivery up to 42 weeks gestation
Ongoing pregnancy rate (%)
Fetal heart beat seen by ultrasound at 20 weeks gestation
Measured: Vaginal ultrasound at 20 weeks of gestation
Clinical pregnancy rate (%)
Fetal heart beat seen by ultrasound at 8 weeks gestation
Measured: Vaginal ultrasound at 8 weeks gestation
Total pregnancy rate (%)
Positive hCG titer
Measured: Up to 15 days from oocyte collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SterilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnny Awwad, American University of Beirut Medical Center
- Investigators
- Johnny Awwad, MD, Principal investigator, AUBMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607319
- Sponsor's protocol ID
- AmericanUBMCRIF
- Acronym
- BRIF
- Status last verified
- Jul 2023
- First submitted
- 11 Nov 2015
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Molecular Weight Heparin (Bemiparin) on Implantation Rate in Patients With Recurrent Implantation Failure Undergoing IVF/ICSI - A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02607319
- Acronym / sponsor ID
- BRIF / AmericanUBMCRIF
- Conditions
- Sterility
- Keywords
- Recurrent Implantation Failure, Implantation, low molecular weight heparin, In vitro Fertilization, Assisted Reproductive Technology, Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Jul 2022 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 18 Nov 2015 (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 objective of this study is to determine the effect of Bemiparin, a low molecular weight heparin, on implantation rate in women with unexplained recurrent implantation failure undergoing IVF/ICSI treatment.
Detailed description
Recurrent implantation failure (RIF), defined as failure of conception following three or more consecutive In Vitro Fertilization (IVF) cycles despite the transfer of good quality embryos, is a major cause of distress amongst infertile couples. While factors underlying implantation failure are many, most cases remain unexplained. In order to improve pregnancy outcomes and delivery rates in women with unexplained RIF, various investigational treatments have been proposed.
The investigators propose a prospective controlled randomized comparative study to evaluate the effect of Bemiparin on implantation rates in women with unexplained RIF. A total of 200 patients will be recruited and randomized between two groups. The study group will receive Bemiparin plus standard care; while the control group will receive only standard care. Treatment will start on the day following embryo transfer and will be continued until 12 weeks gestation in the event of pregnancy.
The primary objective is to determine the effect of Bemiparin on implantation rate in women with unexplained recurrent implantation failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low molecular weight heparin | Experimental | Drug: Bemiparin sodiumBemiparin sodium 3,500 IU anti Xa/0.2 ml solution (Hibor; Laboratories Rovi Pharmaceuticals) for injection in pre-filled syringes. |
| No intervention group | No intervention | –Control group receiving standard care. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- History of three or more consecutively failed In Vitro Fertilization (IVF) cycles after embryo transfer.
- Normal uterine cavity (as assessed by hysteroscopy or HSG).
- Normal hormonal investigation: TSH, PRL, FBS.
- Normal acquired/inherited thrombophilia profile: LAC, ACA IgG/IgM, Prot S, Antithrombin III, beta-2 glycoprotein, Factors V, II, MTHFR.
- Normal semen analysis and mild/moderate male factor (Total motile sperm count > 5 million/ml and/or normal WHO morphology >20%.
Key exclusion criteria (12 listed)
- Evidence of low ovarian reserve by at least one of the following: AMH ≤ 1,5 ng/mL and/or basal CD 3 FSH ≥ 10 mIU/mL and/or basal CD 3 Estradiol ≥ 60 ng/mL and/or previous egg collection yield ≤ 3 oocytes.
- Preexisting medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition…).
- Severe male factor infertility (Total motile sperm count < 5 million/ml and/or normal WHO morphology <20%).
- Hypersensitivity to Heparin or its derivatives.
- Acquired thrombophilia.
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 |
|---|---|---|
| Bemiparin sodiumAlso: HiborBemiparin sodium 3,500 IU will be started on the evening of the same day of embryo transfer and until the day of pregnancy test. If the test is positive, Bemiparin will be discontinued by the end of the 12th week of gestation. | Drug | Low molecular weight heparin |
Primary outcome
Implantation rate (%)
Time frame: Vaginal ultrasound at 8 weeks gestation
Number of intrauterine gestational sacs observed by transvaginal ultrasonography divided by the number of transferred embryos
4 secondary outcomes
Live birth rate (%)
Time frame: Time of delivery up to 42 weeks gestation
Ongoing pregnancy rate (%)
Time frame: Vaginal ultrasound at 20 weeks of gestation
Clinical pregnancy rate (%)
Time frame: Vaginal ultrasound at 8 weeks gestation
Total pregnancy rate (%)
Time frame: Up to 15 days from oocyte collection
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 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Sterility
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.
Johnny Awwad, MD principal investigator
AUBMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bemiparin sodium in people with Sterility, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 12 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 Jul 2023. 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 Lebanon. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Implantation rate (%) (time frame: Vaginal ultrasound at 8 weeks gestation). 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 20 Jul 2023.