The Effect of Heparin in Treatment IVF-ET Failure
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pregnancy Thrombophilia |
Drug: heparin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | the Effect of Unfractionated Heparin in Treatment of IVF-ET Failure |
- chemical pregnancy rate [ Time Frame: until 12th gestational week ] [ Designated as safety issue: No ]
- clinical pregnancy rate [ Time Frame: until 12 gastational week ] [ Designated as safety issue: No ]
| Enrollment: | 86 |
| Study Start Date: | May 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: heparin,pregnancy,IVF failure
Women in the heparin arm are administered 5000 IU twice a day on the day of embryo transfer
|
Drug: heparin
5000 IU subcutaneously in the day of embryo transfer until 6 week after delivery
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 19 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 .
Exclusion Criteria:
- 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 .
Contacts and Locations| Iran, Islamic Republic of | |
| Yazd Research and Clinical Centre for Infertility | |
| Yazd, Iran, Islamic Republic of, 8916877391 | |
| Principal Investigator: | Mehri Mashayekhy, infertility fellowship | Yazd Research and Clinical Centre for Infertility |
More Information
No publications provided
| Responsible Party: | Dr Mehri Mashayekhy, Yazd Research and Clinical centre for infertility |
| ClinicalTrials.gov Identifier: | NCT01214772 History of Changes |
| Other Study ID Numbers: | 1378 |
| Study First Received: | September 28, 2010 |
| Last Updated: | October 1, 2010 |
| Health Authority: | Iran: Ethics Committee |
Keywords provided by Yazd Medical University:
|
pregnancy heparin fertilization |
Additional relevant MeSH terms:
|
Thrombophilia Hematologic Diseases Calcium heparin Heparin Anticoagulants Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013