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

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

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Prednisolone and Heparin during COH for IVF
* Drug: COH for IVF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisolone and Heparin during COH for IVF<br> | Drug: Prednisolone and Heparin during COH for IVF<br>* 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<br>|
| Active Comparator: COH for IVF<br> | Drug: COH for IVF<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | finding of a fetal heart at >6 gestational weeks / 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low molecular weight heparin, Prednisolone, Glucocorticoids, Recurrent implantation failure, Pregnancy rate