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

August 11, 2016 updated by: Mostafa Fouad Gomaa, Ain Shams University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

716

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • Clexane
  • Enoxaparin
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 Names:
  • 0.9% sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth Rate
Time Frame: at delivery
at delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Pregnancy Rate
Time Frame: at 7 weeks of gestation
at 7 weeks of gestation
Biochemical Pregnancy Rate
Time Frame: 14 days after embryo transfer
14 days after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: mostafa f gomaa, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 5, 2016

First Submitted That Met QC Criteria

August 5, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASU-OG-333

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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