Effect of LMWH on Pregnancy Outcome in Women With Multiple Failures of IVF-ET
Effect of Low-Molecular-Weight-Heparin (LMWH) on Pregnancy Outcome in Women With Multiple Failures of IVF-ET
1 other identifier
interventional
240
1 country
3
Brief Summary
Low-Molecular-Weight-Heparin (LMWH) has been used empirically in patients undergoing in-vitro fertilization embryo transfer (IVF-ET) with the purpose to aid in improving pregnancy outcomes. The potential mechanism is that LMWH could exert its anticoagulant effect by inhibiting factor Xa, reducing the risk of insufficiency blood supply in the very early stage of pregnancy. Moreover, LMWH is supposed to play a role in manipulating blastocyst supposition, adhesion, and implantation, as well as trophoblast differentiation and invasion. However, limited high-quality clinical trials focus on the effectivity of LMWH in IVF-ET, and the published evidence is not consensus, leading to considerable controversy in the clinical application of LMWH in IVF-ET patients. Here, investigators try to evaluate the effect of LMWH on pregnancy outcome in women with multiple failures of IVF-ET via a multi-center randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2018
Longer than P75 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2018
CompletedFirst Posted
Study publicly available on registry
October 10, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedJuly 29, 2020
July 1, 2020
3 years
October 7, 2018
July 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live birth rate
Birth of liveborn
Time of delivery up to 42 weeks gestation
Secondary Outcomes (4)
Embryo implantation rate
4 weeks
Clinical pregnancy rate
7-8 weeks
Miscarriage rate
Up to 28 weeks
Ovarian hyperstimulation syndrome (OHSS) rate
Up to 3 weeks after COH
Study Arms (2)
Experimental Arm
EXPERIMENTALLow Molecular Weight Heparin (enoxaparin sodium) + routine luteal phase support
Control Arm
NO INTERVENTIONroutine luteal phase support
Interventions
enoxaparin sodium 40mg/day subcutaneously after oocyte collection, and routine luteal phase support after embryo transfer until clinical pregnancy confirmed by ultrasound
Eligibility Criteria
You may qualify if:
- ≥2 consecutive IVF/ICSI-ET without clinical pregnancy
- ≥2 oocytes retrieval cycles
- \<BMI≤25
- Normal ovarian reserve ( AMH\> 1, FSH \<10 )
- Willing and able to sign the informed consent.
You may not qualify if:
- Uterine abnormalities confirmed by hysterosalpingography or hysteroscopy
- Parental chromosomal abnormalities
- PCOS
- Anti-phospholipid Syndrome
- Endocrine disorder
- Endometriosis
- Hydrosalpinx
- Chronic disease (liver, renal, thyroid, and thrombocytopenia)
- Regular anticoagulation or antiplatelet treatment
- Patients who had contraindication for unfractionated heparin therapy
- History of tuberculosis, HIV, HBV, HCV or tests indicating carriage of HBV or HCV, or positive interferon-gamma release assay in any of the couple
- Enrollment in another clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Clinical Research Center for Reproductive Medicine, Fertility Center, Shenzhen Zhongshan Urology Hospital
Shenzhen, Guangdong, 518045, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Related Publications (3)
Urman B, Ata B, Yakin K, Alatas C, Aksoy S, Mercan R, Balaban B. Luteal phase empirical low molecular weight heparin administration in patients with failed ICSI embryo transfer cycles: a randomized open-labeled pilot trial. Hum Reprod. 2009 Jul;24(7):1640-7. doi: 10.1093/humrep/dep086. Epub 2009 Apr 8.
PMID: 19357135BACKGROUNDNoci I, Milanini MN, Ruggiero M, Papini F, Fuzzi B, Artini PG. Effect of dalteparin sodium administration on IVF outcome in non-thrombophilic young women: a pilot study. Reprod Biomed Online. 2011 Jun;22(6):615-20. doi: 10.1016/j.rbmo.2011.03.016. Epub 2011 Mar 22.
PMID: 21498125BACKGROUNDStern C, Chamley L, Norris H, Hale L, Baker HW. A randomized, double-blind, placebo-controlled trial of heparin and aspirin for women with in vitro fertilization implantation failure and antiphospholipid or antinuclear antibodies. Fertil Steril. 2003 Aug;80(2):376-83. doi: 10.1016/s0015-0282(03)00610-1.
PMID: 12909502BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haixiang Sun, M.D. Ph.D
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- PRINCIPAL INVESTIGATOR
Jing Yang, M.D. Ph.D
Renmin Hospital of Wuhan University
- PRINCIPAL INVESTIGATOR
Ruochun Lian, M.D. Ph.D
Shenzhen Zhongshan Urology Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Hospital
Study Record Dates
First Submitted
October 7, 2018
First Posted
October 10, 2018
Study Start
November 1, 2018
Primary Completion
October 31, 2021
Study Completion
October 31, 2022
Last Updated
July 29, 2020
Record last verified: 2020-07