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

NCT02861105 | Completed Phase 4 DMC

• 1 other identifier: ASU-OG-333
• Study Type: interventional
• Target: 716
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Unexplained Infertility

Outcome Measures

Primary Outcomes (1)

• Live birth Rate

  at delivery

Secondary Outcomes (2)

• Clinical Pregnancy Rate

  at 7 weeks of gestation

• Biochemical Pregnancy Rate

  14 days after embryo transfer

Study Arms (2)

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

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

Other: 0.9% saline solution

Interventions

LMWH DRUG

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.

Also known as: Clexane, Enoxaparin

LMWH supplementation

0.9% saline solution OTHER

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.

Also known as: 0.9% sodium chloride solution

0.9% saline solution

Eligibility Criteria

• Age: Up to 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age less than 38 years
• at least 12 months of infertility
• women with unexplained infertility

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Heparin, Low-Molecular-Weight; Enoxaparin; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mostafa F Gomaa, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 10, 2016
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 12, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share