Effects of Embryogen in RIF Patients

Study Overview
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Brief Summary
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The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with repeated implantation failure (RIF)

Detailed Description
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60 patients with repeated implantation failure were involved. RIF was defined as patients failed to conceive (beta-hCG < 5 mIU/mL) after at least 03 embryo transfers (fresh and frozen) with 06 top quality embryos or more. Ovarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at ﬁxed time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after ovum retrieval. Luteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day; Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was performed at gestational weeks 7 and 12.

Official Title
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Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure

Conditions
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Infertility

Intervention / Treatment
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* Biological: GM-CSF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal ovarian reserve (AMH > 1.1 ng/ml) Regular menstrual cycle (25 - 34 days) Clear informations about at least 3 latest IVF/ET Fresh embryo transfer in this cycle Endometrial thickness of 10 mm or more Exclusion Criteria: Undergo oocyte donation or in vitro maturation (IVM) cycles Using frozen or surgically retrieved sperm Adenomyosis, Uterine anomaly, uterine fibroid, hydrosalpinges In participation in other studies/interventions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GM-CSF<br>Injected oocytes were cultured in GM-CSF supplemented media until day of transfer | Biological: GM-CSF<br>* 2ng/ml of GM-CSF supplemented into culture media<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ongoing pregnancy rate |  | 12 week of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate |  | 7 week of gestation | 
| clinical pregnancy rate |  | 7 week of gestation | 
| top quality embryo rate |  | 44 hours after insemination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GM-CSF, repeated implantation failure