The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers
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|ClinicalTrials.gov Identifier: NCT02861105|
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Unexplained Infertility||Drug: LMWH Other: 0.9% saline solution||Phase 4|
- patients undergoing 1st trial ICSI
- unexplained infertility
- negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||716 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
Active Comparator: 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 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.
Placebo Comparator: 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
Other: 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 Name: 0.9% sodium chloride solution
- Live birth Rate [ Time Frame: at delivery ]
- Clinical Pregnancy Rate [ Time Frame: at 7 weeks of gestation ]
- Biochemical Pregnancy Rate [ Time Frame: 14 days after embryo transfer ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861105
|Principal Investigator:||Mostafa F Gomaa, MD||Ain Shams University|