Addition of Prednisolone and Heparin in Patients Undergoing IVF With Failed IVF Cycles

Infertility Clinical Trial

Official title:

Addition of Prednisolone and Heparin in Patients With Repeated Implantation Failures: a Prospective Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01590173
• Other study ID #: 123123
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 30, 2012
• Last updated: July 17, 2016
• Start date: January 2012
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

The addition of heparin and prednisolone increases pregnancy outcome parameters in women undergoing In Vitro Fertilisation (IVF) with failed IVF cycles.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• personal history of =2 failed IVF/ICSI cycles

• age <45 years

• availability of fresh ejaculate sperm for IVF/ICSI procedures

• confirmation of normal uterine cavity

• presence of good quality (Grade I or II) embryos for transfer

Exclusion Criteria:

• endocrine disorders

• immune disorders

• coagulation disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Prednisolone and Heparin during COH for IVF
Low Molecular Weight Heparin (LMWH) (Enoxaparin Sodium, Clexane, Sanofi-Aventis, Australia) at a dose of 1 mg/kg/day and 5 mg prednisolone p.os (Prezolon; Nycomed Hellas SA) were to be initiated on the first day of injections in both protocols until the pregnancy test. In cases of pregnancy, prednisolone and enoxaparin were to be continued up to the 12th and 34th week, respectively
• COH for IVF
Both GnRH agonists (long, starting at day 2 or 21) with Triptorelin acetate 0.1 mg (Gonapetpyl daily; Ferring, Kiel, Germany) and antagonists' with ganirelix 0.25 mg (Orgalutran; Organon, Oss, The Netherlands) or cetrorelix 0.25 mg (Cetrotide; Serono, Rome, Italy) protocols will be used; for ovarian stimulation both recombinant FSH (Puregon; Organon, Oss, Netherlands or Gonal F; Serono, Rome, Italy) and human menopausal gonadotrophin (Menopur; Ferring Pharmaceuticals, Langley, Berkshire, UK) will be used. Ovarian response will be monitored by ultrasonography, oocyte retrieval will be performed 36-38 hours after the hCG triggering and for luteal phase support 600 mg progesterone tablets (Utrogestan; Laboratoires Besins- Iscovesco, Paris, France) or gel 8% intravaginally (Vasclor; Verisfield Ltd, UK) will be applied.

Locations

Country	Name	City	State
Greece	Assisted Reproduction Unit, 3rd Department of Obstetrics & Gynecology	Athens	Chaidari, Attica

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (4)

Boomsma CM, Keay SD, Macklon NS. Peri-implantation glucocorticoid administration for assisted reproductive technology cycles. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD005996. Review. Update in: Cochrane Database Syst Rev. 2012;6:CD005996. — View Citation

Nelson SM, Greer IA. The potential role of heparin in assisted conception. Hum Reprod Update. 2008 Nov-Dec;14(6):623-45. doi: 10.1093/humupd/dmn031. Epub 2008 Aug 12. Review. — View Citation

Primi MP, Senn A, Montag M, Van der Ven H, Mandelbaum J, Veiga A, Barri P, Germond M. A European multicentre prospective randomized study to assess the use of assisted hatching with a diode laser and the benefit of an immunosuppressive/antibiotic treatment in different patient populations. Hum Reprod. 2004 Oct;19(10):2325-33. Epub 2004 Jul 29. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate		finding of a fetal heart at >6 gestational weeks / 2 years	No
Secondary	miscarriage rate		through study completion, an average of 2 years	No
Secondary	live birth rate		through study completion, an average of 2 years	No
Secondary	biochemical pregnancy rate		through study completion, an average of 2 years	No
Secondary	OHSS		through study completion, an average of 2 years	Yes
Secondary	multiple pregnancy rate		through study completion, an average of 2 years	Yes