The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers
NCT ID: NCT02861105
Last Updated: 2016-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
716 participants
INTERVENTIONAL
2015-01-31
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Local Uterine Application of Low Molecular Weight Heparin (LMWH) in Intra-cytoplasmic Sperm Injection (ICSI)
NCT02325479
Study of Free DNA Content of Embryo Culture Medium as a Non-Invasive Tool for Embryo Assessment
NCT02480491
Semen Processing for ICSI Using Swim-down and Density Gradient Methods
NCT02328534
Evaluation of Some Trace Elements in Follicular Fluid in ICSI Cases and Their Effect on ICSI Outcomes
NCT06719817
Predictive Value of Endometrial Cytokines in Endometrial Implantation in Cases of Intracytoplasmic Sperm Injection
NCT02854514
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. patients undergoing 1st trial ICSI
2. unexplained infertility
3. negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA
Exclusion criteria:
1. previous IVF/ICSI
2. Any cause of infertility
3. Suspected and/or unexpected poor response during ovulation induction
4. positive immunological markers
5. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LMWH supplementation
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
LMWH
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 solution
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
0.9% saline 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LMWH
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 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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* at least 12 months of infertility
* women with unexplained infertility
Exclusion Criteria
* 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
* patients with other than unexplained infertility
* male factor infertility
* refusal of participation
* patients with unexpected poor or over response during induction of ovulation
38 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ain Shams University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mostafa Fouad Gomaa
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mostafa F Gomaa, MD
Role: PRINCIPAL_INVESTIGATOR
Ain Shams University
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ASU-OG-333
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.