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

NCT01590173 | Completed Phase 2

• 1 other identifier: 123123
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infertility

Keywords

Low molecular weight heparin; Prednisolone; Glucocorticoids; Recurrent implantation failure; Pregnancy rate

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  finding of a fetal heart at >6 gestational weeks / 2 years

Secondary Outcomes (5)

• miscarriage rate

  through study completion, an average of 2 years

• live birth rate

  through study completion, an average of 2 years

• biochemical pregnancy rate

  through study completion, an average of 2 years

• OHSS

  through study completion, an average of 2 years

• multiple pregnancy rate

  through study completion, an average of 2 years

Study Arms (2)

Prednisolone and Heparin during COH for IVF

EXPERIMENTAL

Drug: Prednisolone and Heparin during COH for IVF

COH for IVF

ACTIVE COMPARATOR

Drug: COH for IVF

Interventions

Prednisolone and Heparin during COH for IVF DRUG

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

Prednisolone and Heparin during COH for IVF

COH for IVF DRUG

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.

COH for IVF

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• endocrine disorders
• immune disorders
• coagulation disorders

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Assisted Reproduction Unit, 3rd Department of Obstetrics & Gynecology

Athens, Chaidari, Attica, 12642, Greece

Location

Related Publications (4)

• 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: 19357135 BACKGROUND

• Boomsma CM, Keay SD, Macklon NS. Peri-implantation glucocorticoid administration for assisted reproductive technology cycles. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD005996. doi: 10.1002/14651858.CD005996.pub2.

  PMID: 17253574 BACKGROUND

• 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.

  PMID: 18701511 BACKGROUND

• 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. doi: 10.1093/humrep/deh430. Epub 2004 Jul 29.

  PMID: 15284215 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Charalampos Siristatidis, MD, PhD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer, Director of the IVF Unit

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 2, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07

Locations

GR (1)