Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT02861105
Status:
COMPLETED
Last Update Posted:
2016-08-12
First Post:
2016-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Inclusion criteria:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: