Infertility Clinical Trial
Official title:
Local Uterine Application of Low Molecular Weight Heparin (LMWH) in Intra-cytoplasmic Sperm Injection (ICSI) a Randomised Controlled Pilot Study
Verified date | February 2016 |
Source | The Egyptian IVF-ET Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Interventional |
Heparin also has the ability to bind with and modulate a wide variety of proteins, which can
influence a number of physiological processes involved in implantation & trophoblastic
development. These processes include adhesion of the blastocyst to the endometrial surface &
trophoblastic differentiation & invasion.
A recent Cochrane review hinted towards research to study the possible effects of the local
(uterine), & NOT SYSTEMIC application of heparin during Assisted reproductive technology
(ART). Based on the above evidence the investigators hypothesize that low molecular weight
heparin given intrauterine at mock embryo transfer after oocyte pick up will help improve
pregnancy rates in patients undergoing ART.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 37 Years |
Eligibility |
Inclusion Criteria: 1. Normal serum prolactin level & thyroid stimulating hormone (TSH) 2. Unexplained infertility 3. Tubal factor infertility 4. BMI <30 kg/m2 Exclusion Criteria: 1. Reduced ovarian reserve by AFC, Anti-mullerian hormone (AMH) 2. Presence of non disconnected hydrosalpinges 3. Frozen embryo transfer cycles 4. Uterine Anomalies 5. Submucous fibroids and polyps 6. Uterine synechia 7. Contraindication of pregnancy e.g.: Somatic and mental diseases, which are contraindications for carrying of a pregnancy and childbirth, inborn malformations or acquired deformations of uterus cavity which make embryo implantation or carrying of a pregnancy impossible ,ovarian tumors |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | The Egyptian IVF-ET Center | Cairo | Maadi |
Lead Sponsor | Collaborator |
---|---|
The Egyptian IVF-ET Center |
Egypt,
Akhtar MA, Sur S, Raine-Fenning N, Jayaprakasan K, Thornton J, Quenby S, Marjoribanks J. Heparin for assisted reproduction: summary of a Cochrane review. Fertil Steril. 2015 Jan;103(1):33-4. doi: 10.1016/j.fertnstert.2014.09.005. Epub 2014 Oct 1. Review. — View Citation
Mansour R, Tawab N, Kamal O, El-Faissal Y, Serour A, Aboulghar M, Serour G. Intrauterine injection of human chorionic gonadotropin before embryo transfer significantly improves the implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomized study. Fertil Steril. 2011 Dec;96(6):1370-1374.e1. doi: 10.1016/j.fertnstert.2011.09.044. Epub 2011 Nov 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pregnancy rate | safety | 14 days | Yes |
Secondary | Early miscarriage rate | 12 weeks | No | |
Secondary | Implanation rate | 3 weeks after ET | No |
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