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

Primary Purpose

Infertility

Status

Completed

Phase

Phase 2

Locations

Greece

Study Type

Interventional

Intervention

Prednisolone and Heparin during COH for IVF

COH for IVF

About this trial

This is an interventional treatment trial for Infertility focused on measuring Low molecular weight heparin, Prednisolone, Glucocorticoids, Recurrent implantation failure, Pregnancy rate

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Assisted Reproduction Unit, 3rd Department of Obstetrics & Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prednisolone and Heparin during COH for IVF

COH for IVF

Arm Description

Outcomes

Primary Outcome Measures

clinical pregnancy rate

Secondary Outcome Measures

miscarriage rate

live birth rate

biochemical pregnancy rate

OHSS

multiple pregnancy rate

Full Information

NCT ID

NCT01590173

First Posted

April 30, 2012

Last Updated

July 17, 2016

Sponsor

National and Kapodistrian University of Athens

1. Study Identification

Unique Protocol Identification Number

NCT01590173

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National and Kapodistrian University of Athens

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prednisolone and Heparin during COH for IVF

Arm Type

Experimental

Arm Title

COH for IVF

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Prednisolone and Heparin during COH for IVF

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

COH for IVF

Intervention Description

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.

Primary Outcome Measure Information:

Title

clinical pregnancy rate

Time Frame

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

Secondary Outcome Measure Information:

Title

miscarriage rate

Time Frame