The Effect of Heparin in Treatment IVF-ET Failure

NCT01214772 | Completed Phase 4 DMC

• 1 other identifier: 1378
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Embryo transfer failure is defined as ≥3 IVF-embryo transfer failures without pregnancy . In spite of transfer of 3 good quality embryos , just 20-30% of women undergoing IVF will achieve ongoing pregnancy . There are multiple factors that influence IVF-failure. Autoantibodies may be one of the possible causes of IVF-failure , especially in unexplained and mechanical infertility . In some studies , antiphospholipid antibody is considered as causative factor on implantation and embryo failure. However some investigators showed that combination therapy with heparin/aspirin in women with positive antiphospholipid antibody is not effective in improving of IVF-outcome . In prospective studies were not confirmed association between antiphospholipid antibody abnormalities and IVF-failure. Recently has been relationship between thrombophilia and IVF and implantation failure. The effect of unfractionated heparin in assisted reproductive technology (ART) cycles is prevention of thrombosis in implantation site . Although its effect is not restricted to anticoagulation and also can modulate apposition , adhesion , and penetration of embryo . Other advantages are decreasing thrombophilic risk in COH ( controlled ovarian hyperstimulation) cycles with administration of gonadotrophins . So heparin make better pregnancy rate in repeated IVF-ET failures. There are few studies in regard to heparin effects on IVF cycles outcome . The purpose of this study is evaluation of unfractionated heparin effects on improvement of ART outcome . This study was a prospective randomized controlled trial to assess whether administration of heparin would increased pregnancy rates in women with repeated ET-IVF failures.

Conditions

Pregnancy; Thrombophilia

Keywords

pregnancy; heparin; fertilization

Outcome Measures

Primary Outcomes (1)

• chemical pregnancy rate

  until 12th gestational week

Secondary Outcomes (1)

• clinical pregnancy rate

  until 12 gastational week

Study Arms (1)

heparin,pregnancy,IVF failure

EXPERIMENTAL

Women in the heparin arm are administered 5000 IU twice a day on the day of embryo transfer

Drug: heparin

Interventions

heparin DRUG

5000 IU subcutaneously in the day of embryo transfer until 6 week after delivery

heparin,pregnancy,IVF failure

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who were 19-35 years old
• basal FSH \< 10 IU/l
• body mass index ( BMI ) \< 29 Kg/m²
• presence of both ovaries
• three or more pervious IVF-ET failures
• Top-quality embryos for transfer .

You may not qualify if:

• Women with polycystic ovary syndrome ( PCOS)
• endometriosis
• hydrosalpinx
• chronic systemic disease( liver, renal , thyroid and thrombocytopenia ) ●Abnormal uterine cavity
• sever male factor ( azospermia )
• Patients who had contraindication for unfractionated heparin therapy .

Sponsors & Collaborators

• Yazd Medical University: lead
• Yazd Research & Clinical Center for Infertility: collaborator

Study Sites (1)

Yazd Research and Clinical Centre for Infertility

Yazd, Yazd Province, 8916877391, Iran

Location

MeSH Terms

Conditions

Thrombophilia

Interventions

Heparin

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Mehri Mashayekhy, infertility fellowship

  Yazd Research and Clinical Centre for Infertility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: October 5, 2010
• Study Start: May 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: June 1, 2010
• Last Updated: October 5, 2010

Record last verified: 2010-10

Locations

IR (1)