The Effect of LMWH on ICSI in Patients With Unexplained Infertility and Negative Immunological Markers

Unexplained Infertility Clinical Trial

Official title:

The Effect of LMWH on ICSI Outcome in Patients With Unexplained Infertility and Negative Immunological Markers; a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861105
• Other study ID #: ASU-OG-333
• Status: Completed
• Phase: Phase 4
• First received: August 5, 2016
• Last updated: August 11, 2016
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 716
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 38 Years

Eligibility

Inclusion Criteria:

• age less than 38 years

• at least 12 months of infertility

• women with unexplained infertility

Exclusion Criteria:

• 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

• patients with other than unexplained infertility

• male factor infertility

• refusal of participation

• patients with unexpected poor or over response during induction of ovulation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Unexplained Infertility

Intervention

Drug:
• 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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth Rate		at delivery	No
Secondary	Clinical Pregnancy Rate		at 7 weeks of gestation	No
Secondary	Biochemical Pregnancy Rate		14 days after embryo transfer	No