Effects of Embryogen in RIF Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-08-31

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)

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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.

Conditions

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Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GM-CSF

Injected oocytes were cultured in GM-CSF supplemented media until day of transfer

Group Type EXPERIMENTAL

GM-CSF

Intervention Type BIOLOGICAL

2ng/ml of GM-CSF supplemented into culture media

Interventions

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GM-CSF

2ng/ml of GM-CSF supplemented into culture media

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes