Skip to main content
OpenTrials
Completed

NCT Number: NCT02861105

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

The purpose of this study is to assess the efficacy of LMWH treatment in women with unexplained infertility and negative immunological markers undergoing ICSI.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Unexplained Infertility

Age range

Up to 38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

Inclusion criteria

  • patients undergoing 1st trial ICSI
  • unexplained infertility
  • negative immunological markers including ACL abs, LAC, ANA, ATA, AnitdsDNA

Exclusion criteria

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Clexane, Enoxaparin

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.

Other names: 0.9% sodium chloride solution

Primary outcomes

  1. Live birth Rate

    Time frame: at delivery

Secondary outcomes

  1. Clinical Pregnancy Rate

    Time frame: at 7 weeks of gestation

  2. Biochemical Pregnancy Rate

    Time frame: 14 days after embryo transfer

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 10, 2016
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.