Unexplained InfertilityPhase 4NCT02861105
The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers
A Phase 4 study testing LMWH and 0.9% saline solution in people with Unexplained Infertility, run by Ain Shams University.
Trial summary
The purpose of this study is to assess the efficacy of LMWH treatment in women with unexplained infertility and negative immunological markers undergoing ICSI. Read more about this study
- Who is it for?
- Ages Up to 38 years, women only
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- LMWH and 0.9% saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 716 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2016
- 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 Up to 38 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- age less than 38 years
- at least 12 months of infertility
- women with unexplained infertility
Who cannot join
- age more than or equals 38 years
- serum AMH level less than or equals 1 ng/ml
- patients of anticoagulant therapy
- immune-compromised patients
- patients with contraindications to low molecular weight heparin
- positive immunological markers
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- patients with other than unexplained infertility
- male factor infertility
- refusal of participation
- patients with unexpected poor or over response during induction of ovulation
About this study
Official title: The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial
The purpose of this study is to assess the efficacy of LMWH treatment in women with unexplained infertility and negative immunological markers undergoing ICSI.
Read the detailed description
Inclusion criteria:
- patients undergoing 1st trial ICSI
- unexplained infertility
- negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA
Exclusion criteria:
- previous IVF/ICSI
- Any cause of infertility
- Suspected and/or unexpected poor response during ovulation induction
- positive immunological markers
- Age > 40 years.
All participants will undergo IVF/ICSI cycle using the Long luteal phase protocol. the dose of gonadotropins will be calculated according to patient age and BMI. All patients will have 2-3 embryos transferred at D5 according to their age. the primary outcome will be LBR. secondary outcomes will include biochemical pregnancy rate and clinical pregnancy rate.
- Conditions
- Unexplained Infertility
- Being tested
- LMWH, 0.9% saline solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMWHDrug
Also called Clexane, Enoxaparin
LMWH will be given on daily basis subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.
0.9% saline solutionOther
Also called 0.9% sodium chloride solution
0.9% saline solution will be given subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LMWH supplementation | Active comparator | 40 mg of enoxaparin injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation Receives: Drug: LMWH |
| 0.9% saline solution | Placebo comparator | 0.9% saline injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation Receives: Other: 0.9% saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth Rate
Measured: at delivery
Secondary outcomes (2)
Clinical Pregnancy Rate
Measured: at 7 weeks of gestation
Biochemical Pregnancy Rate
Measured: 14 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained InfertilityStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 716 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Fouad Gomaa, Ain Shams University
- Investigators
- Mostafa F Gomaa, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861105
- Sponsor's protocol ID
- ASU-OG-333
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02861105
- Acronym / sponsor ID
- ASU-OG-333
- Conditions
- Unexplained Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 716 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Aug 2016 (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 this study is to assess the efficacy of LMWH treatment in women with unexplained infertility and negative immunological markers undergoing ICSI.
Detailed description
Inclusion criteria:
- patients undergoing 1st trial ICSI
- unexplained infertility
- negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA
Exclusion criteria:
- previous IVF/ICSI
- Any cause of infertility
- Suspected and/or unexpected poor response during ovulation induction
- positive immunological markers
- Age > 40 years.
All participants will undergo IVF/ICSI cycle using the Long luteal phase protocol. the dose of gonadotropins will be calculated according to patient age and BMI. All patients will have 2-3 embryos transferred at D5 according to their age. the primary outcome will be LBR. secondary outcomes will include biochemical pregnancy rate and clinical pregnancy rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMWH supplementation | Active comparator | Drug: LMWH40 mg of enoxaparin injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation |
| 0.9% saline solution | Placebo comparator | Other: 0.9% saline solution0.9% saline injected subcutaneously every 24 hours starting the day of ovum pick-up to the documentation of fetal life by ultrasound at 7 weeks of gestation |
Who may qualify
- Ages
- Up to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age less than 38 years
- at least 12 months of infertility
- women with unexplained infertility
Key exclusion criteria (10 listed)
- age more than or equals 38 years
- serum AMH level less than or equals 1 ng/ml
- patients of anticoagulant therapy
- immune-compromised patients
- patients with contraindications to low molecular weight heparin
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 |
|---|---|---|
| LMWHAlso: Clexane, EnoxaparinLMWH will be given on daily basis subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks. | Drug | LMWH supplementation |
| 0.9% saline solutionAlso: 0.9% sodium chloride solution0.9% saline solution will be given subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks. | Other | 0.9% saline solution |
Primary outcome
Live birth Rate
Time frame: at delivery
2 secondary outcomes
Clinical Pregnancy Rate
Time frame: at 7 weeks of gestation
Biochemical Pregnancy Rate
Time frame: 14 days after embryo transfer
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 12 Aug 2016.
- 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.
Mostafa F Gomaa, MD principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LMWH and 0.9% saline solution in people with Unexplained Infertility, run by Ain Shams University.
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 10 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 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Live birth Rate (time frame: at delivery). 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 12 Aug 2016.